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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01776424




Registration number
NCT01776424
Ethics application status
Date submitted
24/01/2013
Date registered
28/01/2013
Date last updated
28/11/2022

Titles & IDs
Public title
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
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).
Secondary ID [1] 0 0
2012-004180-43
Secondary ID [2] 0 0
15786
Universal Trial Number (UTN)
Trial acronym
COMPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention & Control 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
Timepoint [2] 0 0
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.
Secondary outcome [1] 0 0
The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
All-cause Mortality
Timepoint [3] 0 0
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.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
Accrual to date
Final
27395
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Bruce
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- New Lambton Heights
Recruitment hospital [4] 0 0
- Taree
Recruitment hospital [5] 0 0
- Birtinya
Recruitment hospital [6] 0 0
- Brisbane
Recruitment hospital [7] 0 0
- Redcliffe
Recruitment hospital [8] 0 0
- Woolloongabba
Recruitment hospital [9] 0 0
- Adelaide
Recruitment hospital [10] 0 0
- Hobart
Recruitment hospital [11] 0 0
- Launceston
Recruitment hospital [12] 0 0
- Geelong
Recruitment hospital [13] 0 0
- Melbourne
Recruitment hospital [14] 0 0
- Prahran
Recruitment hospital [15] 0 0
- Murdoch
Recruitment hospital [16] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2430 - Taree
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4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
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4064 - Brisbane
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4020 - Redcliffe
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5042 - Adelaide
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment postcode(s) [12] 0 0
7250 - Launceston
Recruitment postcode(s) [13] 0 0
3220 - Geelong
Recruitment postcode(s) [14] 0 0
3052 - Melbourne
Recruitment postcode(s) [15] 0 0
3181 - Melbourne
Recruitment postcode(s) [16] 0 0
3181 - Prahran
Recruitment postcode(s) [17] 0 0
6150 - Murdoch
Recruitment postcode(s) [18] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Santa Fe
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Tucuman
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Argentina
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Argentina
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Corrientes
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Salta
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Turku
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Vantaa
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Bottrop
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Chiba
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Ehime
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Fukuoka
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Gunma
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Hyogo
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Ishikawa
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Kanagawa
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Okinawa
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Osaka
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Saitama
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Tokushima
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Tokyo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Janssen Research & Development, LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01776424
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01776424