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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01776424
Registration number
NCT01776424
Ethics application status
Date submitted
24/01/2013
Date registered
28/01/2013
Titles & IDs
Public title
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
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Scientific title
A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
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Secondary ID [1]
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2012-004180-43
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Secondary ID [2]
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15786
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Universal Trial Number (UTN)
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Trial acronym
COMPASS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prevention & Control
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Aspirin
Treatment: Drugs - Aspirin placebo
Treatment: Drugs - Rivaroxaban placebo
Treatment: Drugs - Pantoprazole
Treatment: Drugs - Pantoprazole placebo
Experimental: Rivaroxaban 2.5mg + Aspirin 100mg - Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Experimental: Rivaroxaban 5mg + Aspirin Placebo - Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Active comparator: Rivaroxaban Placebo + Aspirin 100mg - Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 2.5 mg, twice daily, oral
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 5 mg, twice daily, oral
Treatment: Drugs: Aspirin
Tablet, 100 mg, once daily, oral
Treatment: Drugs: Aspirin placebo
Aspirin matching placebo, once daily, oral
Treatment: Drugs: Rivaroxaban placebo
Rivaroxaban matching placebo, twice daily, oral
Treatment: Drugs: Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Treatment: Drugs: Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
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Assessment method [1]
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Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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Timepoint [1]
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For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
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Primary outcome [2]
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The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
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Assessment method [2]
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Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).
Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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Timepoint [2]
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For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
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Secondary outcome [1]
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The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death
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Assessment method [1]
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Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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Timepoint [1]
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For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
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Secondary outcome [2]
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The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death
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Assessment method [2]
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Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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Timepoint [2]
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For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
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Secondary outcome [3]
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All-cause Mortality
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Assessment method [3]
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Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
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Timepoint [3]
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For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
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Eligibility
Key inclusion criteria
- Meet criteria for CAD and/or PAD
Subjects with CAD must also meet at least one of the following criteria:
* Age =65, or
* Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Stroke within 1 month or any history of hemorrhagic or lacunar stroke
* Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms
* Estimated glomerular filtration rate (eGFR)<15 mL/min
* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/02/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/06/2021
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Sample size
Target
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Accrual to date
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Final
27395
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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- Bruce
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- Gosford
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- New Lambton Heights
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- Taree
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- Birtinya
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- Brisbane
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- Redcliffe
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- Woolloongabba
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- Adelaide
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- Hobart
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- Launceston
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- Nedlands
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Recruitment postcode(s) [1]
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2617 - Bruce
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2250 - Gosford
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2305 - New Lambton Heights
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2430 - Taree
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4575 - Birtinya
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4029 - Brisbane
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Recruitment postcode(s) [7]
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4064 - Brisbane
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4020 - Redcliffe
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4102 - Woolloongabba
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5042 - Adelaide
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7000 - Hobart
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7250 - Launceston
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3220 - Geelong
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3052 - Melbourne
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Recruitment postcode(s) [15]
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3181 - Melbourne
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Recruitment postcode(s) [16]
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3181 - Prahran
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Recruitment postcode(s) [17]
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6150 - Murdoch
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Recruitment postcode(s) [18]
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6009 - Nedlands
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Recruitment outside Australia
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Czechia
Query!
State/province [97]
0
0
Praha 13
Query!
Country [98]
0
0
Czechia
Query!
State/province [98]
0
0
Praha 2
Query!
Country [99]
0
0
Czechia
Query!
State/province [99]
0
0
Praha 4
Query!
Country [100]
0
0
Czechia
Query!
State/province [100]
0
0
Praha 5
Query!
Country [101]
0
0
Czechia
Query!
State/province [101]
0
0
Praha 6
Query!
Country [102]
0
0
Czechia
Query!
State/province [102]
0
0
Slany
Query!
Country [103]
0
0
Czechia
Query!
State/province [103]
0
0
Susice
Query!
Country [104]
0
0
Czechia
Query!
State/province [104]
0
0
Trebic
Query!
Country [105]
0
0
Czechia
Query!
State/province [105]
0
0
Trinec
Query!
Country [106]
0
0
Czechia
Query!
State/province [106]
0
0
Uherske Hradiste
Query!
Country [107]
0
0
Czechia
Query!
State/province [107]
0
0
Zlin
Query!
Country [108]
0
0
Denmark
Query!
State/province [108]
0
0
Aalborg
Query!
Country [109]
0
0
Denmark
Query!
State/province [109]
0
0
Aarhus N
Query!
Country [110]
0
0
Denmark
Query!
State/province [110]
0
0
Hellerup
Query!
Country [111]
0
0
Denmark
Query!
State/province [111]
0
0
Holbaek
Query!
Country [112]
0
0
Denmark
Query!
State/province [112]
0
0
Hvidovre
Query!
Country [113]
0
0
Denmark
Query!
State/province [113]
0
0
Kolding
Query!
Country [114]
0
0
Denmark
Query!
State/province [114]
0
0
København Ø
Query!
Country [115]
0
0
Denmark
Query!
State/province [115]
0
0
København
Query!
Country [116]
0
0
Denmark
Query!
State/province [116]
0
0
Viborg
Query!
Country [117]
0
0
Ecuador
Query!
State/province [117]
0
0
Guayas
Query!
Country [118]
0
0
Ecuador
Query!
State/province [118]
0
0
Pichincha
Query!
Country [119]
0
0
Ecuador
Query!
State/province [119]
0
0
Quito
Query!
Country [120]
0
0
Finland
Query!
State/province [120]
0
0
Kuopio
Query!
Country [121]
0
0
Finland
Query!
State/province [121]
0
0
Kuusankoski
Query!
Country [122]
0
0
Finland
Query!
State/province [122]
0
0
Tampere
Query!
Country [123]
0
0
Finland
Query!
State/province [123]
0
0
Turku
Query!
Country [124]
0
0
Finland
Query!
State/province [124]
0
0
Vantaa
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Amiens cedex 1
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Clermont Ferrand
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Limoges Cedex
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Montpellier
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Nice
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
NIMES cedex 9
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Paris Cedex 15
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Paris
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Saint-priest-en-jarez
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Bayern
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Hessen
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Nordrhein-Westfalen
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Sachsen-Anhalt
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Sachsen
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Berlin
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Bottrop
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Frankfurt
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Hamburg
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Warendorf
Query!
Country [144]
0
0
Hungary
Query!
State/province [144]
0
0
Balatonfured
Query!
Country [145]
0
0
Hungary
Query!
State/province [145]
0
0
Budapest
Query!
Country [146]
0
0
Hungary
Query!
State/province [146]
0
0
Debrecen
Query!
Country [147]
0
0
Hungary
Query!
State/province [147]
0
0
Mosonmagyarovar
Query!
Country [148]
0
0
Hungary
Query!
State/province [148]
0
0
Pecs
Query!
Country [149]
0
0
Hungary
Query!
State/province [149]
0
0
Sopron
Query!
Country [150]
0
0
Hungary
Query!
State/province [150]
0
0
Szekesfehervar
Query!
Country [151]
0
0
Hungary
Query!
State/province [151]
0
0
Szekszard
Query!
Country [152]
0
0
Ireland
Query!
State/province [152]
0
0
Co. Galway
Query!
Country [153]
0
0
Ireland
Query!
State/province [153]
0
0
Cork
Query!
Country [154]
0
0
Ireland
Query!
State/province [154]
0
0
Dublin
Query!
Country [155]
0
0
Ireland
Query!
State/province [155]
0
0
Galway
Query!
Country [156]
0
0
Israel
Query!
State/province [156]
0
0
Afula
Query!
Country [157]
0
0
Israel
Query!
State/province [157]
0
0
Ashkelon
Query!
Country [158]
0
0
Israel
Query!
State/province [158]
0
0
Bnei Brak
Query!
Country [159]
0
0
Israel
Query!
State/province [159]
0
0
Haifa
Query!
Country [160]
0
0
Israel
Query!
State/province [160]
0
0
Holon
Query!
Country [161]
0
0
Israel
Query!
State/province [161]
0
0
Nahariya
Query!
Country [162]
0
0
Israel
Query!
State/province [162]
0
0
Tel Aviv
Query!
Country [163]
0
0
Israel
Query!
State/province [163]
0
0
Zefat
Query!
Country [164]
0
0
Italy
Query!
State/province [164]
0
0
Campania
Query!
Country [165]
0
0
Italy
Query!
State/province [165]
0
0
Emilia-Romagna
Query!
Country [166]
0
0
Italy
Query!
State/province [166]
0
0
Friuli-Venezia Giulia
Query!
Country [167]
0
0
Italy
Query!
State/province [167]
0
0
Lombardia
Query!
Country [168]
0
0
Italy
Query!
State/province [168]
0
0
Marche
Query!
Country [169]
0
0
Italy
Query!
State/province [169]
0
0
Molise
Query!
Country [170]
0
0
Italy
Query!
State/province [170]
0
0
Puglia
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Sicilia
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Toscana
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Umbria
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Aichi
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Chiba
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Ehime
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Fukuoka
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Gunma
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Hiroshima
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Hokkaido
Query!
Country [181]
0
0
Japan
Query!
State/province [181]
0
0
Hyogo
Query!
Country [182]
0
0
Japan
Query!
State/province [182]
0
0
Ishikawa
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Kanagawa
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Okinawa
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Osaka
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Saitama
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Tokushima
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Tokyo
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Yamaguchi
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Gifu
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Kumamoto
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Kyoto
Query!
Country [193]
0
0
Korea, Republic of
Query!
State/province [193]
0
0
Gang''weondo
Query!
Country [194]
0
0
Korea, Republic of
Query!
State/province [194]
0
0
Gyeonggido
Query!
Country [195]
0
0
Korea, Republic of
Query!
State/province [195]
0
0
Jejudo
Query!
Country [196]
0
0
Korea, Republic of
Query!
State/province [196]
0
0
Seoul Teugbyeolsi
Query!
Country [197]
0
0
Korea, Republic of
Query!
State/province [197]
0
0
Busan
Query!
Country [198]
0
0
Korea, Republic of
Query!
State/province [198]
0
0
Daejeon
Query!
Country [199]
0
0
Korea, Republic of
Query!
State/province [199]
0
0
Seoul
Query!
Country [200]
0
0
Malaysia
Query!
State/province [200]
0
0
Batu Caves, Selangor
Query!
Country [201]
0
0
Malaysia
Query!
State/province [201]
0
0
Kedah
Query!
Country [202]
0
0
Malaysia
Query!
State/province [202]
0
0
Kuala Lumpur
Query!
Country [203]
0
0
Malaysia
Query!
State/province [203]
0
0
Selangor
Query!
Country [204]
0
0
Malaysia
Query!
State/province [204]
0
0
Sungai Buloh Selangor
Query!
Country [205]
0
0
Netherlands
Query!
State/province [205]
0
0
Amsterdam
Query!
Country [206]
0
0
Netherlands
Query!
State/province [206]
0
0
Apeldoorn
Query!
Country [207]
0
0
Netherlands
Query!
State/province [207]
0
0
Arnhem
Query!
Country [208]
0
0
Netherlands
Query!
State/province [208]
0
0
Breda
Query!
Country [209]
0
0
Netherlands
Query!
State/province [209]
0
0
Delft
Query!
Country [210]
0
0
Netherlands
Query!
State/province [210]
0
0
Den Bosch
Query!
Country [211]
0
0
Netherlands
Query!
State/province [211]
0
0
Deventer
Query!
Country [212]
0
0
Netherlands
Query!
State/province [212]
0
0
Doetinchem
Query!
Country [213]
0
0
Netherlands
Query!
State/province [213]
0
0
Drachten
Query!
Country [214]
0
0
Netherlands
Query!
State/province [214]
0
0
EDE
Query!
Country [215]
0
0
Netherlands
Query!
State/province [215]
0
0
Gorinchem
Query!
Country [216]
0
0
Netherlands
Query!
State/province [216]
0
0
Gouda
Query!
Country [217]
0
0
Netherlands
Query!
State/province [217]
0
0
Groningen
Query!
Country [218]
0
0
Netherlands
Query!
State/province [218]
0
0
Heerlen
Query!
Country [219]
0
0
Netherlands
Query!
State/province [219]
0
0
Helmond
Query!
Country [220]
0
0
Netherlands
Query!
State/province [220]
0
0
Hoogeveen
Query!
Country [221]
0
0
Netherlands
Query!
State/province [221]
0
0
Hoorn
Query!
Country [222]
0
0
Netherlands
Query!
State/province [222]
0
0
Leeuwarden
Query!
Country [223]
0
0
Netherlands
Query!
State/province [223]
0
0
Meppel
Query!
Country [224]
0
0
Netherlands
Query!
State/province [224]
0
0
Nijmegen
Query!
Country [225]
0
0
Netherlands
Query!
State/province [225]
0
0
Roermond
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Roosendaal
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Rotterdam
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Sneek
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Tiel
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Zwolle
Query!
Country [231]
0
0
Philippines
Query!
State/province [231]
0
0
Batangas
Query!
Country [232]
0
0
Philippines
Query!
State/province [232]
0
0
Cebu City
Query!
Country [233]
0
0
Philippines
Query!
State/province [233]
0
0
Dagupan City
Query!
Country [234]
0
0
Philippines
Query!
State/province [234]
0
0
Dasmarinas
Query!
Country [235]
0
0
Philippines
Query!
State/province [235]
0
0
Iloilo City
Query!
Country [236]
0
0
Philippines
Query!
State/province [236]
0
0
Laoag City
Query!
Country [237]
0
0
Philippines
Query!
State/province [237]
0
0
Manila
Query!
Country [238]
0
0
Philippines
Query!
State/province [238]
0
0
Metro Manila
Query!
Country [239]
0
0
Philippines
Query!
State/province [239]
0
0
Muntinlupa City
Query!
Country [240]
0
0
Philippines
Query!
State/province [240]
0
0
Palawan
Query!
Country [241]
0
0
Philippines
Query!
State/province [241]
0
0
Pasig city
Query!
Country [242]
0
0
Philippines
Query!
State/province [242]
0
0
Quezon City
Query!
Country [243]
0
0
Philippines
Query!
State/province [243]
0
0
Tacloban City
Query!
Country [244]
0
0
Poland
Query!
State/province [244]
0
0
Gdansk
Query!
Country [245]
0
0
Poland
Query!
State/province [245]
0
0
Kielce
Query!
Country [246]
0
0
Poland
Query!
State/province [246]
0
0
Krakow
Query!
Country [247]
0
0
Poland
Query!
State/province [247]
0
0
Lodz
Query!
Country [248]
0
0
Poland
Query!
State/province [248]
0
0
Tarnow
Query!
Country [249]
0
0
Poland
Query!
State/province [249]
0
0
Wroclaw
Query!
Country [250]
0
0
Romania
Query!
State/province [250]
0
0
Timis
Query!
Country [251]
0
0
Romania
Query!
State/province [251]
0
0
Brasov
Query!
Country [252]
0
0
Romania
Query!
State/province [252]
0
0
Bucharest
Query!
Country [253]
0
0
Romania
Query!
State/province [253]
0
0
Bucuresti
Query!
Country [254]
0
0
Romania
Query!
State/province [254]
0
0
Cluj Napoca
Query!
Country [255]
0
0
Romania
Query!
State/province [255]
0
0
Iasi
Query!
Country [256]
0
0
Romania
Query!
State/province [256]
0
0
Targu Mures
Query!
Country [257]
0
0
Romania
Query!
State/province [257]
0
0
Timisoara
Query!
Country [258]
0
0
Russian Federation
Query!
State/province [258]
0
0
Barnaul
Query!
Country [259]
0
0
Russian Federation
Query!
State/province [259]
0
0
Kemerovo
Query!
Country [260]
0
0
Russian Federation
Query!
State/province [260]
0
0
Moscow
Query!
Country [261]
0
0
Russian Federation
Query!
State/province [261]
0
0
Novosibirsk
Query!
Country [262]
0
0
Russian Federation
Query!
State/province [262]
0
0
Tomsk
Query!
Country [263]
0
0
Russian Federation
Query!
State/province [263]
0
0
Zhukovskiy
Query!
Country [264]
0
0
Slovakia
Query!
State/province [264]
0
0
Bratislava
Query!
Country [265]
0
0
Slovakia
Query!
State/province [265]
0
0
Kosice
Query!
Country [266]
0
0
Slovakia
Query!
State/province [266]
0
0
Nitra
Query!
Country [267]
0
0
Slovakia
Query!
State/province [267]
0
0
Presov
Query!
Country [268]
0
0
Slovakia
Query!
State/province [268]
0
0
Vrable
Query!
Country [269]
0
0
South Africa
Query!
State/province [269]
0
0
Eastern Cape
Query!
Country [270]
0
0
South Africa
Query!
State/province [270]
0
0
Freestate
Query!
Country [271]
0
0
South Africa
Query!
State/province [271]
0
0
Gauteng
Query!
Country [272]
0
0
South Africa
Query!
State/province [272]
0
0
Western Cape
Query!
Country [273]
0
0
South Africa
Query!
State/province [273]
0
0
Somerset West
Query!
Country [274]
0
0
Sweden
Query!
State/province [274]
0
0
Göteborg
Query!
Country [275]
0
0
Sweden
Query!
State/province [275]
0
0
Helsingborg
Query!
Country [276]
0
0
Sweden
Query!
State/province [276]
0
0
Kristianstad
Query!
Country [277]
0
0
Sweden
Query!
State/province [277]
0
0
Skellefteå
Query!
Country [278]
0
0
Sweden
Query!
State/province [278]
0
0
Stockholm
Query!
Country [279]
0
0
Sweden
Query!
State/province [279]
0
0
Vällingby
Query!
Country [280]
0
0
Sweden
Query!
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Örebro
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Sweden
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Östersund
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Switzerland
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Ticino
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Simferopol
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Ukraine
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Vinnitsa
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Ukraine
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Zaporozhye
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United Kingdom
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Antrim
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United Kingdom
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Derry
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United Kingdom
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Essex
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United Kingdom
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Hertfordshire
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Lancashire
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London
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United Kingdom
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North Ireland
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North Yorkshire
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Northamptonshire
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United Kingdom
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Stockton-on-Tees
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United Kingdom
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Warwickshire
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United Kingdom
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West Midlands
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Worcestershire
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Funding & Sponsors
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Commercial sector/industry
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Name
Bayer
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Other
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Population Health Research Institute
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Commercial sector/industry
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Janssen Research & Development, LLC
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Summary
Brief summary
The primary objectives of this study are: * To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); * To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.
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Trial website
https://clinicaltrials.gov/study/NCT01776424
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Trial related presentations / publications
Eikelboom JW, Bosch J, Connolly SJ, Tyrwitt J, Fox KAA, Muehlhofer E, Neumann C, Tasto C, Bangdiwala SI, Diaz R, Alings M, Dagenais GR, Leong DP, Lonn EM, Avezum A, Piegas LS, Widimsky P, Parkhomenko AN, Bhatt DL, Branch KRH, Probstfield JL, Lopez-Jaramillo P, Ryden L, Pogosova N, Keltai K, Keltai M, Ertl G, Stoerk S, Dans AL, Lanas F, Liang Y, Zhu J, Torp-Pedersen C, Maggioni AP, Commerford PJ, Guzik TJ, Vanassche T, Verhamme P, O'Donnell M, Tonkin AM, Varigos JD, Vinereanu D, Felix C, Kim JH, Ibrahim KS, Lewis BS, Metsarinne KP, Aboyans V, Steg PG, Hori M, Kakkar A, Anand SS, Lamy A, Sharma M, Yusuf S. Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):786-795. doi: 10.1093/ehjcvp/pvac023. Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11. Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-6736(17)32409-1. PMID:29132880 Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32458-3. doi: 10.1016/S0140-6736(17)32458-3. PMID:29132879 Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27. Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lanius V, Yuan F, Misselwitz F, Chen E, Diaz R, Alings M, Lonn EM, Widimsky P, Hori M, Avezum A, Piegas LS, Bhatt DL, Branch KRH, Probstfield JL, Liang Y, Liu L, Zhu J, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Fox KAA, Kakkar A, Parkhomenko AN, Ertl G, Stork S, Keltai K, Keltai M, Ryden L, Dagenais GR, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Ha JW, Tonkin AM, Varigos JD, Lewis BS, Felix C, Yusoff K, Steg PG, Aboyans V, Metsarinne KP, Anand SS, Hart RG, Lamy A, Moayyedi P, Leong DP, Sharma M, Yusuf S. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial. Can J Cardiol. 2017 Aug;33(8):1027-1035. doi: 10.1016/j.cjca.2017.06.001. Epub 2017 Jun 8. Braunwald E. An Important Step for Thrombocardiology. N Engl J Med. 2017 Oct 5;377(14):1387-1388. doi: 10.1056/NEJMe1710241. Epub 2017 Aug 27. No abstract available. Fauchier L, Bisson A, Angoulvant D. Rivaroxaban in Stable Cardiovascular Disease. N Engl J Med. 2018 Jan 26;378(4):395. doi: 10.1056/NEJMc1714934. No abstract available. Berger JS. Antithrombotic therapy in peripheral artery disease. Lancet. 2018 Jan 20;391(10117):183-184. doi: 10.1016/S0140-6736(17)32847-7. Epub 2017 Nov 10. No abstract available. Darmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, Bosch J, Branch KR, Connolly SJ, Dyal L, Eikelboom JW, Fox KAA, Keltai K, Probstfield J, Yusuf S, Abtan J, Sorbets E, Eagle KA, Ducrocq G, Steg PG. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018 Mar 1;39(9):750-757a. doi: 10.1093/eurheartj/ehx658. Verheugt FWA. Return of Oral Anticoagulation in Chronic Stable Coronary Disease. Circulation. 2018 Apr 17;137(16):1655-1657. doi: 10.1161/CIRCULATIONAHA.117.032916. No abstract available. Fox KAA, Eikelboom JW, Anand SS, Bhatt DL, Bosch J, Connolly SJ, Harrington RA, Steg PG, Yusuf S. Anti-thrombotic options for secondary prevention in patients with chronic atherosclerotic vascular disease: what does COMPASS add? Eur Heart J. 2019 May 7;40(18):1466-1471. doi: 10.1093/eurheartj/ehy347. No abstract available. Sharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casanova A, Eikelboom JW, Connolly SJ, Wong G, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KR, Probstfield JL, Kim JH, Ha JW, O'Donnell M, Vinereanu D, Fox KA, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Cook Bruns N, Berkowitz S, Yusuf S. Rationale, design, and baseline participant characteristics in the MRI and cognitive substudy of the cardiovascular outcomes for people using anticoagulation strategies trial. Int J Stroke. 2019 Apr;14(3):270-281. doi: 10.1177/1747493018784478. Epub 2018 Jul 30. Kruger PC, Eikelboom JW, Yusuf S. Rivaroxaban with or without aspirin for prevention of cardiovascular disease. Coron Artery Dis. 2018 Aug;29(5):361-365. doi: 10.1097/MCA.0000000000000605. No abstract available. Ademi Z, Zomer E, Tonkin A, Liew D. Cost-effectiveness of rivaroxaban and aspirin compared to aspirin alone in patients with stable cardiovascular disease: An Australian perspective. Int J Cardiol. 2018 Nov 1;270:54-59. doi: 10.1016/j.ijcard.2018.06.091. Epub 2018 Jun 25. Bhagirath VC, Eikelboom JW, Anand SS. Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Future Cardiol. 2018 Nov;14(6):443-453. doi: 10.2217/fca-2018-0059. Epub 2018 Nov 12. Kruger PC, Anand SS, de Vries TAC, Eikelboom JW. Patients with Peripheral Artery Disease in the COMPASS Trial. Eur J Vasc Endovasc Surg. 2018 Dec;56(6):772-773. doi: 10.1016/j.ejvs.2018.08.010. Epub 2018 Sep 10. No abstract available. Boden WE, Bhatt DL. Will COMPASS Point to a New Direction in Thrombotic Risk Reduction in Patients With Stable Cardiovascular Disease? Circulation. 2018 Aug 28;138(9):858-860. doi: 10.1161/CIRCULATIONAHA.118.035405. No abstract available. Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J, Fox KAA, Zhu J, Lonn E, Dagenais G, Widimsky P, Branch KRH, Bhatt DL, Zheng Z, Straka Z, Dagenais F, Kong Y, Marsden T, Lee SF, Copland I, Yusuf S. Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study. J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048. Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakovska O, Ng KKH, Catanese L, Keltai K, Aboyans V, Alings M, Ha JW, Varigos J, Tonkin A, O'Donnell M, Bhatt DL, Fox K, Maggioni A, Berkowitz SD, Bruns NC, Yusuf S, Eikelboom JW. Stroke Outcomes in the COMPASS Trial. Circulation. 2019 Feb 26;139(9):1134-1145. doi: 10.1161/CIRCULATIONAHA.118.035864. Coppens M, Weitz JI, Eikelboom JWA. Synergy of Dual Pathway Inhibition in Chronic Cardiovascular Disease. Circ Res. 2019 Feb;124(3):416-425. doi: 10.1161/CIRCRESAHA.118.313141. Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Cook Bruns N, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar A, Parkhomenko AN, Ryden L, Pogosova N, Dans A, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik T, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne K, Fox KAA, Yusuf S; COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology. 2019 Aug;157(2):403-412.e5. doi: 10.1053/j.gastro.2019.04.041. Epub 2019 May 2. Fox KAA, Eikelboom JW, Shestakovska O, Connolly SJ, Metsarinne KP, Yusuf S. Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction: From the COMPASS Trial. J Am Coll Cardiol. 2019 May 14;73(18):2243-2250. doi: 10.1016/j.jacc.2019.02.048. Cairns JA, Eikelboom JW, Shestakovska O, Yusuf S, DeMets D. Monitoring Emerging Data From the COMPASS Trial of an Antithrombotic Agent. J Am Coll Cardiol. 2019 Jun 4;73(21):2769-2772. doi: 10.1016/j.jacc.2019.03.479. No abstract available. Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29. Kruger PC, Guzik TJ, Eikelboom JW. How can the results of the COMPASS trial benefit patients with coronary or peripheral artery disease in Poland? Kardiol Pol. 2019 Aug 23;77(7-8):661-669. doi: 10.33963/KP.14855. Epub 2019 May 30. Branch KR, Probstfield JL, Eikelboom JW, Bosch J, Maggioni AP, Cheng RK, Bhatt DL, Avezum A, Fox KAA, Connolly SJ, Shestakovska O, Yusuf S. Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):529-537. doi: 10.1161/CIRCULATIONAHA.119.039609. Epub 2019 Jun 5. Darmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, Popovic B, Ohman EM, Rother J, Wilson PF, Montalescot G, Zeymer U, Bhatt DL, Steg PG; REACH Registry Investigators. Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients. J Am Coll Cardiol. 2019 Jul 2;73(25):3281-3291. doi: 10.1016/j.jacc.2019.04.046. Anand SS, Eikelboom JW, Dyal L, Bosch J, Neumann C, Widimsky P, Avezum AA, Probstfield J, Cook Bruns N, Fox KAA, Bhatt DL, Connolly SJ, Yusuf S; COMPASS Trial Investigators. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. J Am Coll Cardiol. 2019 Jul 2;73(25):3271-3280. doi: 10.1016/j.jacc.2019.02.079. Fox KAA, Metra M, Morais J, Atar D. The myth of 'stable' coronary artery disease. Nat Rev Cardiol. 2020 Jan;17(1):9-21. doi: 10.1038/s41569-019-0233-y. Epub 2019 Jul 29. de Vries TI, Eikelboom JW, Bosch J, Westerink J, Dorresteijn JAN, Alings M, Dyal L, Berkowitz SD, van der Graaf Y, Fox KAA, Visseren FLJ. Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial. Eur Heart J. 2019 Dec 7;40(46):3771-3778a. doi: 10.1093/eurheartj/ehz404. Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Ryden L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis. Circulation. 2019 Oct 29;140(18):1451-1459. doi: 10.1161/CIRCULATIONAHA.119.041949. Epub 2019 Sep 12. Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sharma M, Connolly SJ, Yusuf S, Bosch J, Eikelboom JW, Hart RG. Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial. JAMA Neurol. 2020 Jan 1;77(1):43-48. doi: 10.1001/jamaneurol.2019.2984. Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska O, Dagenais GR, Hart RG, Leong DP, O'Donnell M, Fox KAA, Bhatt DL, Cairns JA, Tasto C, Berkowitz SD, Cook Bruns N, Muehlhofer E, Diaz R, Maggioni AP, Yusuf S. Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin. J Am Coll Cardiol. 2019 Sep 24;74(12):1519-1528. doi: 10.1016/j.jacc.2019.07.065. Wurtz M, Olesen KKW, Thim T, Kristensen SD, Eikelboom JW, Maeng M. External applicability of the COMPASS trial: the Western Denmark Heart Registry. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):192-199. doi: 10.1093/ehjcvp/pvz013. Vanassche T, Verhamme P, Anand SS, Shestakovska O, Fox KA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial. Eur J Prev Cardiol. 2020 Feb;27(3):296-307. doi: 10.1177/2047487319882154. Epub 2019 Oct 15. Cowie MR, Lamy A, Levy P, Mealing S, Millier A, Mernagh P, Cristeau O, Bowrin K, Briere JB. Health economic evaluation of rivaroxaban in the treatment of patients with chronic coronary artery disease or peripheral artery disease. Cardiovasc Res. 2020 Sep 1;116(11):1918-1924. doi: 10.1093/cvr/cvz278. Welsh RC, Peterson ED, De Caterina R, Bode C, Gersh B, Eikelboom JW. Applying contemporary antithrombotic therapy in the secondary prevention of chronic atherosclerotic cardiovascular disease. Am Heart J. 2019 Dec;218:100-109. doi: 10.1016/j.ahj.2019.09.006. Epub 2019 Oct 23. Schiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3. Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch J, Fox KAA, Steg PG, Vinereanu D, Connolly DL, Berkowitz SD, Foody JM, Probstfield JL, Branch KR, Lewis BS, Diaz R, Muehlhofer E, Widimsky P, Yusuf S, Eikelboom JW, Bhatt DL; COMPASS Investigators. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI). Circulation. 2020 Apr 7;141(14):1141-1151. doi: 10.1161/CIRCULATIONAHA.119.044598. Epub 2020 Mar 17. Erratum In: Circulation. 2020 Jun 9;141(23):e905. doi: 10.1161/CIR.0000000000000847. Liang Y, Zhu J, Liu L, Anand SS, Connolly SJ, Bosch J, Guzik TJ, O'Donnell M, Dagenais GR, Fox KA, Shestakovska O, Berkowitz SD, Muehlhofer E, Keller L, Yusuf S, Eikelboom JW; COMPASS Investigators. Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease. Cardiovasc Res. 2021 Feb 22;117(3):942-949. doi: 10.1093/cvr/cvaa100. Erratum In: Cardiovasc Res. 2021 May 25;117(6):1577. doi: 10.1093/cvr/cvaa182. Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anand SS, Verma S, Branch KRH, Probstfield J, Bosch J, Shestakovska O, Szarek M, Maggioni AP, Widimsky P, Avezum A, Diaz R, Lewis BS, Berkowitz SD, Fox KAA, Ryden L, Yusuf S; COMPASS Steering Committee and Investigators. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation. 2020 Jun 9;141(23):1841-1854. doi: 10.1161/CIRCULATIONAHA.120.046448. Epub 2020 Mar 28. Steffel J, Eikelboom JW, Anand SS, Shestakovska O, Yusuf S, Fox KAA. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48. doi: 10.1161/CIRCULATIONAHA.120.046048. Epub 2020 May 21. Erratum In: Circulation. 2020 Jul 7;142(1):e23. doi: 10.1161/CIR.0000000000000880. Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW, Connolly SJ, Dyal L, Reeh KW, Casanova A, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KRH, Probstfield JL, Kim JH, O'Donnell M, Vinereanu D, A A Fox K, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Berkowitz SD, Yusuf S. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy. Stroke. 2020 Oct;51(10):2901-2909. doi: 10.1161/STROKEAHA.120.029762. Epub 2020 Sep 21. Erratum In: Stroke. 2021 Jan;52(2):e90. doi: 10.1161/STR.0000000000000360. Kaplovitch E, Eikelboom JW, Dyal L, Aboyans V, Abola MT, Verhamme P, Avezum A, Fox KAA, Berkowitz SD, Bangdiwala SI, Yusuf S, Anand SS. Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):21-29. doi: 10.1001/jamacardio.2020.4390. Erratum In: JAMA Cardiol. 2021 Feb 1;6(2):246. doi: 10.1001/jamacardio.2020.6442. Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-Jaramillo P, Dyal L, Berkowitz SD, Muehlhofer E, Bhatt DL, Fox KAA, Yusuf S, Eikelboom JW. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial. J Am Coll Cardiol. 2021 Feb 9;77(5):511-525. doi: 10.1016/j.jacc.2020.11.061. Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD, Yusuf S, Verhamme P, Vanassche T, Anand SS, Fox KAA, Eikelboom JW, Amerena J; COMPASS Trial Investigators. Risk stratification of cardiovascular complications using CHA2DS2-VASc and CHADS2 scores in chronic atherosclerotic cardiovascular disease. Int J Cardiol. 2021 Aug 15;337:9-15. doi: 10.1016/j.ijcard.2021.04.067. Epub 2021 May 3. Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V, Berkowitz SD, Bhatt DL, Connolly SJ, Fox KAA, Muehlhofer E, Probstfield JL, Widimsky P, Winkelmann BR, Yusuf S, Eikelboom JW. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease. Heart. 2021 Jul;107(14):1130-1137. doi: 10.1136/heartjnl-2020-318758. Epub 2021 May 21. Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686. Erratum In: JAMA Cardiol. 2021 Oct 1;6(10):1223. doi: 10.1001/jamacardio.2021.3351. Vanassche T, Verhamme P, Anand SS, Shestakovska O, Leong DP, Fox KAA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Muehlhofer E, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Low-dose rivaroxaban plus aspirin in patients with polypharmacy and multimorbidity: an analysis from the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):462-473. doi: 10.1093/ehjcvp/pvab050. Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly SJ, Anand SS, Avezum A, Berkowitz SD, Branch KRH, Dagenais GR, Felix C, Guzik TJ, Hart RG, Maggioni AP, Muehlhofer E, Sharma M, Shestakovska O, Yusuf S. Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol. 2021 Jul 6;78(1):14-23. doi: 10.1016/j.jacc.2021.04.083. Anand SS, Hiatt W, Dyal L, Bauersachs R, Berkowitz SD, Branch KRH, Debus S, Fox KAA, Liang Y, Muehlhofer E, Nehler M, Haskell LP, Patel M, Szarek M, Yusuf S, Eikelboom J, Bonaca MP. Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials. Eur J Prev Cardiol. 2022 May 5;29(5):e181-e189. doi: 10.1093/eurjpc/zwab128. Kaplovitch E, Anand SS. The evolving treatment of peripheral arterial disease: preventing ischaemic events in the post-COMPASS era. Cardiovasc Res. 2019 Oct 1;115(12):e121-e124. doi: 10.1093/cvr/cvz170. No abstract available. Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S. The cost-effectiveness of rivaroxaban with or without aspirin in the COMPASS trial. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):502-510. doi: 10.1093/ehjqcco/qcac054. Catanese L, Eikelboom JW, Bosch J, Shestakovska O, Ng K, Nayar S, Perera KS, Shoamanesh A, Sharma M, Hart RG. Oral factor Xa inhibitors and risk of subdural hematoma: COMPASS trial results and meta-analysis. Neurology. 2020 Aug 4;95(5):e480-e487. doi: 10.1212/WNL.0000000000009826. Epub 2020 Jul 10. Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Stork S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10. Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10. Erratum In: Lancet. 2018 Jan 20;391(10117):204. doi: 10.1016/S0140-6736(17)33365-2.
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT01776424/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT01776424/SAP_003.pdf
Results publications and other study-related documents
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Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, ...
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Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz...
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Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dy...
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Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, H...
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Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lani...
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Braunwald E. An Important Step for Thrombocardiolo...
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Fauchier L, Bisson A, Angoulvant D. Rivaroxaban in...
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Berger JS. Antithrombotic therapy in peripheral ar...
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Darmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, B...
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Verheugt FWA. Return of Oral Anticoagulation in Ch...
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Fox KAA, Eikelboom JW, Anand SS, Bhatt DL, Bosch J...
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Sharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casa...
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Kruger PC, Eikelboom JW, Yusuf S. Rivaroxaban with...
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Ademi Z, Zomer E, Tonkin A, Liew D. Cost-effective...
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Bhagirath VC, Eikelboom JW, Anand SS. Low-dose riv...
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Kruger PC, Anand SS, de Vries TAC, Eikelboom JW. P...
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Boden WE, Bhatt DL. Will COMPASS Point to a New Di...
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Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J,...
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Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakov...
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Coppens M, Weitz JI, Eikelboom JWA. Synergy of Dua...
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Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dy...
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Fox KAA, Eikelboom JW, Shestakovska O, Connolly SJ...
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Cairns JA, Eikelboom JW, Shestakovska O, Yusuf S, ...
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Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dy...
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Kruger PC, Guzik TJ, Eikelboom JW. How can the res...
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Branch KR, Probstfield JL, Eikelboom JW, Bosch J, ...
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Darmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, ...
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Anand SS, Eikelboom JW, Dyal L, Bosch J, Neumann C...
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Fox KAA, Metra M, Morais J, Atar D. The myth of 's...
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de Vries TI, Eikelboom JW, Bosch J, Westerink J, D...
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Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O...
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Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sh...
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Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska ...
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Wurtz M, Olesen KKW, Thim T, Kristensen SD, Eikelb...
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Vanassche T, Verhamme P, Anand SS, Shestakovska O,...
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Cowie MR, Lamy A, Levy P, Mealing S, Millier A, Me...
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Welsh RC, Peterson ED, De Caterina R, Bode C, Gers...
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Schiele F, Puymirat E, Ferrieres J, Simon T, Fox K...
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Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch...
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Liang Y, Zhu J, Liu L, Anand SS, Connolly SJ, Bosc...
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Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anan...
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Steffel J, Eikelboom JW, Anand SS, Shestakovska O,...
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Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW...
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Kaplovitch E, Eikelboom JW, Dyal L, Aboyans V, Abo...
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Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-...
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Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD...
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Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V...
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Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, No...
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Vanassche T, Verhamme P, Anand SS, Shestakovska O,...
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Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly...
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Anand SS, Hiatt W, Dyal L, Bauersachs R, Berkowitz...
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Kaplovitch E, Anand SS. The evolving treatment of ...
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Results are available at
https://clinicaltrials.gov/study/NCT01776424