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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02415400
Registration number
NCT02415400
Ethics application status
Date submitted
9/04/2015
Date registered
14/04/2015
Date last updated
11/06/2020
Titles & IDs
Public title
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
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Scientific title
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
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Secondary ID [1]
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2014-002004-24
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Secondary ID [2]
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CV185-316
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Other cardiovascular diseases
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Cardiovascular
0
0
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0
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Coronary heart disease
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Other
0
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Active comparator: Apixaban - 5 mg or 2.5 mg Apixaban tablets orally twice per day
Active comparator: Vitamin K Antagonist - VKA tablets orally once daily
Placebo comparator: Acetylsalicylic acid film coated tablet - 81 mg Acetylsalicylic acid film coated tablet orally once daily
Placebo comparator: Placebo matching Acetylsalicylic acid film coated tablet - Placebo matching Acetylsalicylic acid film coated tablet once daily
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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 Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
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Assessment method [1]
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Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
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Timepoint [1]
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Approximately 6 months
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Primary outcome [2]
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The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period
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Assessment method [2]
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Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.
N is the number of participants with aspirin or placebo.
n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
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Timepoint [2]
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Approximately 6 months
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Secondary outcome [1]
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Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA
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Assessment method [1]
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Time to first occurrence during the time the participants were treated with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
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Timepoint [1]
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Approximately 6 months
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Secondary outcome [2]
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The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA
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Assessment method [2]
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Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
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Timepoint [2]
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Approximately 6 months
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Secondary outcome [3]
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The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin
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Assessment method [3]
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Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.
N is the number of participants treated with aspirin or placebo.
n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
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Timepoint [3]
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Approximately 6 months
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Secondary outcome [4]
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The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA
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Assessment method [4]
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Time to first occurrence during the 6-month treatment period with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.
Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
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Timepoint [4]
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Approximately 6 months
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Secondary outcome [5]
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The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin
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Assessment method [5]
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Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.
N is the number of participants treated with aspirin or placebo.
n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.
Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
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Timepoint [5]
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Approximately 6 months
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
* Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
* Planned use of antiplatelet agents for at least 1 to 6 months
* Males and Females = 18 years of age
* Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
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Minimum age
18
Years
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Maximum age
95
Years
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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
* Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
* Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
* Patients with a history of intracranial hemorrhage
* Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
* Patients with known ongoing bleeding and patients with known coagulopathies
* Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin
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Study design
Purpose of the study
Other
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 4
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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
4/06/2015
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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
10/11/2018
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Sample size
Target
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Accrual to date
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Final
4614
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Local Institution - Concord
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Local Institution - Port Macquarie
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Local Institution - Milton
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Recruitment hospital [4]
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Local Institution - Elizabeth Vale
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Recruitment hospital [5]
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Local Institution - Bedford Park
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Recruitment postcode(s) [1]
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2139 - Concord
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2444 - Port Macquarie
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Recruitment postcode(s) [3]
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4064 - Milton
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Recruitment postcode(s) [4]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [5]
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5024 - Bedford Park
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Recruitment outside Australia
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Distrito Federal
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Para
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Burgas
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Dimitrovgrad
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Vidin
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Croatia
Query!
State/province [108]
0
0
Slavonski Brod
Query!
Country [109]
0
0
Croatia
Query!
State/province [109]
0
0
Virovitica
Query!
Country [110]
0
0
Croatia
Query!
State/province [110]
0
0
Zabok
Query!
Country [111]
0
0
Croatia
Query!
State/province [111]
0
0
Zadar
Query!
Country [112]
0
0
Croatia
Query!
State/province [112]
0
0
Zagreb
Query!
Country [113]
0
0
Czechia
Query!
State/province [113]
0
0
Prague 8
Query!
Country [114]
0
0
Czechia
Query!
State/province [114]
0
0
Praha 2
Query!
Country [115]
0
0
Czechia
Query!
State/province [115]
0
0
Praha 5
Query!
Country [116]
0
0
Czechia
Query!
State/province [116]
0
0
Tabor
Query!
Country [117]
0
0
Czechia
Query!
State/province [117]
0
0
Usti Nad Orlici
Query!
Country [118]
0
0
Czechia
Query!
State/province [118]
0
0
Zlin
Query!
Country [119]
0
0
Denmark
Query!
State/province [119]
0
0
Aabenraa
Query!
Country [120]
0
0
Denmark
Query!
State/province [120]
0
0
Aarhus
Query!
Country [121]
0
0
Denmark
Query!
State/province [121]
0
0
Copenhagen
Query!
Country [122]
0
0
Denmark
Query!
State/province [122]
0
0
Frederiksburg
Query!
Country [123]
0
0
Denmark
Query!
State/province [123]
0
0
Hellerup
Query!
Country [124]
0
0
Denmark
Query!
State/province [124]
0
0
Hillerod
Query!
Country [125]
0
0
Denmark
Query!
State/province [125]
0
0
Holb?k
Query!
Country [126]
0
0
Denmark
Query!
State/province [126]
0
0
Hvidovre
Query!
Country [127]
0
0
Denmark
Query!
State/province [127]
0
0
Randers
Query!
Country [128]
0
0
Denmark
Query!
State/province [128]
0
0
Roskilde
Query!
Country [129]
0
0
Denmark
Query!
State/province [129]
0
0
Slagelse
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Besancon
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Caen
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Chambray-les-Tours
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Le Coudray
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Lyon
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Marseille
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Nimes
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Pau
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Pessac
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Toulouse
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Bad Friedrichshall
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Bad Homburg
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Berlin
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Bielefeld
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Brandenburg
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Bremen
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Chemnitz
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Dortmund
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Dresden
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Erfurt
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Erlangen
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Essen
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Frankfurt am Main
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Freiburg
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Gottingen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Greifswald
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Hamburg
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Hansestadt Stendal
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Hennigsdorf
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Hoyerswerda
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Jena
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Karlsbad
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Kassel
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Koln
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Lahr
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Leipzig
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Limburg
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Ludenscheid
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Luebeck
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Magdeburg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Mainz
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Mannheim
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Neuss
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Papenburg
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Regensburg
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Rostock
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Straubing
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Tubingen
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Ulm
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Villingen-Schwenningen
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Weiden i.d.OPf.
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Worms
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Wurzburg
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Bacs-kiskun
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Bekescsaba
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Budapest
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Keszthely
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Mosonmagyarovar
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Pecs
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Szeged
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Szekszard
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Szolnok
Query!
Country [192]
0
0
India
Query!
State/province [192]
0
0
Gujarat
Query!
Country [193]
0
0
India
Query!
State/province [193]
0
0
Karnataka
Query!
Country [194]
0
0
India
Query!
State/province [194]
0
0
Amritsar
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Jaipur,
Query!
Country [196]
0
0
India
Query!
State/province [196]
0
0
Lucknow
Query!
Country [197]
0
0
India
Query!
State/province [197]
0
0
Madurai
Query!
Country [198]
0
0
India
Query!
State/province [198]
0
0
Mangalore
Query!
Country [199]
0
0
India
Query!
State/province [199]
0
0
New Delhi
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Noida
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Shivamogga
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Vadodara
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Vijayawada
Query!
Country [204]
0
0
Israel
Query!
State/province [204]
0
0
Afula
Query!
Country [205]
0
0
Israel
Query!
State/province [205]
0
0
Ashkelon
Query!
Country [206]
0
0
Israel
Query!
State/province [206]
0
0
Hadera
Query!
Country [207]
0
0
Israel
Query!
State/province [207]
0
0
Haifa
Query!
Country [208]
0
0
Israel
Query!
State/province [208]
0
0
Herzliya
Query!
Country [209]
0
0
Israel
Query!
State/province [209]
0
0
Holon
Query!
Country [210]
0
0
Israel
Query!
State/province [210]
0
0
Jerusalem
Query!
Country [211]
0
0
Israel
Query!
State/province [211]
0
0
Ramat-Gan
Query!
Country [212]
0
0
Israel
Query!
State/province [212]
0
0
Rehovot
Query!
Country [213]
0
0
Israel
Query!
State/province [213]
0
0
Safed
Query!
Country [214]
0
0
Israel
Query!
State/province [214]
0
0
Tel Aviv
Query!
Country [215]
0
0
Israel
Query!
State/province [215]
0
0
Tiberias
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Grosseto
Query!
Country [217]
0
0
Korea, Republic of
Query!
State/province [217]
0
0
Busan
Query!
Country [218]
0
0
Korea, Republic of
Query!
State/province [218]
0
0
Changwon
Query!
Country [219]
0
0
Korea, Republic of
Query!
State/province [219]
0
0
Daegu
Query!
Country [220]
0
0
Korea, Republic of
Query!
State/province [220]
0
0
Daejeon
Query!
Country [221]
0
0
Korea, Republic of
Query!
State/province [221]
0
0
Gwang Ju
Query!
Country [222]
0
0
Korea, Republic of
Query!
State/province [222]
0
0
Incheon
Query!
Country [223]
0
0
Korea, Republic of
Query!
State/province [223]
0
0
Seongnam-si
Query!
Country [224]
0
0
Korea, Republic of
Query!
State/province [224]
0
0
Seoul
Query!
Country [225]
0
0
Mexico
Query!
State/province [225]
0
0
Coahuila
Query!
Country [226]
0
0
Mexico
Query!
State/province [226]
0
0
Guanajuato
Query!
Country [227]
0
0
Mexico
Query!
State/province [227]
0
0
Jalisco
Query!
Country [228]
0
0
Mexico
Query!
State/province [228]
0
0
Nuevo LEON
Query!
Country [229]
0
0
Mexico
Query!
State/province [229]
0
0
Queretaro
Query!
Country [230]
0
0
Mexico
Query!
State/province [230]
0
0
QUE
Query!
Country [231]
0
0
Mexico
Query!
State/province [231]
0
0
Sinaloa
Query!
Country [232]
0
0
Mexico
Query!
State/province [232]
0
0
Aguascalientes
Query!
Country [233]
0
0
Mexico
Query!
State/province [233]
0
0
Durango
Query!
Country [234]
0
0
Mexico
Query!
State/province [234]
0
0
Puebla
Query!
Country [235]
0
0
Mexico
Query!
State/province [235]
0
0
San Luis Potosi
Query!
Country [236]
0
0
Mexico
Query!
State/province [236]
0
0
Tlalnepantla De Baz
Query!
Country [237]
0
0
Mexico
Query!
State/province [237]
0
0
Veracruz
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
Amsterdam
Query!
Country [239]
0
0
Netherlands
Query!
State/province [239]
0
0
Arnhem
Query!
Country [240]
0
0
Netherlands
Query!
State/province [240]
0
0
Breda
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Ede
Query!
Country [242]
0
0
Netherlands
Query!
State/province [242]
0
0
Groningen
Query!
Country [243]
0
0
Netherlands
Query!
State/province [243]
0
0
Hardenberg
Query!
Country [244]
0
0
Netherlands
Query!
State/province [244]
0
0
Maastricht
Query!
Country [245]
0
0
Netherlands
Query!
State/province [245]
0
0
Nieuwegein
Query!
Country [246]
0
0
Netherlands
Query!
State/province [246]
0
0
Rotterdam
Query!
Country [247]
0
0
Netherlands
Query!
State/province [247]
0
0
Tilburg
Query!
Country [248]
0
0
Netherlands
Query!
State/province [248]
0
0
Uden
Query!
Country [249]
0
0
Norway
Query!
State/province [249]
0
0
Bod?
Query!
Country [250]
0
0
Norway
Query!
State/province [250]
0
0
Oslo
Query!
Country [251]
0
0
Norway
Query!
State/province [251]
0
0
Skien
Query!
Country [252]
0
0
Norway
Query!
State/province [252]
0
0
Stavanger
Query!
Country [253]
0
0
Norway
Query!
State/province [253]
0
0
Tromso
Query!
Country [254]
0
0
Peru
Query!
State/province [254]
0
0
Lima
Query!
Country [255]
0
0
Peru
Query!
State/province [255]
0
0
Callao
Query!
Country [256]
0
0
Peru
Query!
State/province [256]
0
0
Cusco
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Wielkopolskie
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Bialystok
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Bydgoszcz
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Bytom
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Chojnice
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Gdynia
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Katowice
Query!
Country [264]
0
0
Poland
Query!
State/province [264]
0
0
Kielce
Query!
Country [265]
0
0
Poland
Query!
State/province [265]
0
0
Krakow
Query!
Country [266]
0
0
Poland
Query!
State/province [266]
0
0
Lodz
Query!
Country [267]
0
0
Poland
Query!
State/province [267]
0
0
Lubin
Query!
Country [268]
0
0
Poland
Query!
State/province [268]
0
0
Opole
Query!
Country [269]
0
0
Poland
Query!
State/province [269]
0
0
Plock
Query!
Country [270]
0
0
Poland
Query!
State/province [270]
0
0
Siemianowice Slaskie
Query!
Country [271]
0
0
Poland
Query!
State/province [271]
0
0
Torun
Query!
Country [272]
0
0
Poland
Query!
State/province [272]
0
0
Warszawa
Query!
Country [273]
0
0
Poland
Query!
State/province [273]
0
0
Wloclawek
Query!
Country [274]
0
0
Poland
Query!
State/province [274]
0
0
Wroclaw
Query!
Country [275]
0
0
Portugal
Query!
State/province [275]
0
0
Almada
Query!
Country [276]
0
0
Portugal
Query!
State/province [276]
0
0
Aveiro
Query!
Country [277]
0
0
Portugal
Query!
State/province [277]
0
0
Braga
Query!
Country [278]
0
0
Portugal
Query!
State/province [278]
0
0
Coimbra
Query!
Country [279]
0
0
Portugal
Query!
State/province [279]
0
0
Covilha
Query!
Country [280]
0
0
Portugal
Query!
State/province [280]
0
0
Guimar?es
Query!
Country [281]
0
0
Portugal
Query!
State/province [281]
0
0
Leiria
Query!
Country [282]
0
0
Portugal
Query!
State/province [282]
0
0
Lisbon
Query!
Country [283]
0
0
Portugal
Query!
State/province [283]
0
0
Senhora De Hora, Matosinhos
Query!
Country [284]
0
0
Portugal
Query!
State/province [284]
0
0
Vila Real
Query!
Country [285]
0
0
Puerto Rico
Query!
State/province [285]
0
0
Caguas
Query!
Country [286]
0
0
Romania
Query!
State/province [286]
0
0
Baia Mare
Query!
Country [287]
0
0
Romania
Query!
State/province [287]
0
0
Brasov
Query!
Country [288]
0
0
Romania
Query!
State/province [288]
0
0
Bucharest
Query!
Country [289]
0
0
Romania
Query!
State/province [289]
0
0
Cluj-Napoca
Query!
Country [290]
0
0
Romania
Query!
State/province [290]
0
0
Craiova
Query!
Country [291]
0
0
Romania
Query!
State/province [291]
0
0
Oradea
Query!
Country [292]
0
0
Romania
Query!
State/province [292]
0
0
Pitesti
Query!
Country [293]
0
0
Romania
Query!
State/province [293]
0
0
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Pfizer
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Duke Clinical Research Institute
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Summary
Brief summary
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.
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Trial website
https://clinicaltrials.gov/study/NCT02415400
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Trial related presentations / publications
Bahit MC, Vora AN, Li Z, Wojdyla DM, Thomas L, Goodman SG, Aronson R, Jordan JD, Kolls BJ, Dombrowski KE, Vinereanu D, Halvorsen S, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander JH, Lopes RD. Apixaban or Warfarin and Aspirin or Placebo After Acute Coronary Syndrome or Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Prior Stroke: A Post Hoc Analysis From the AUGUSTUS Trial. JAMA Cardiol. 2022 Jul 1;7(7):682-689. doi: 10.1001/jamacardio.2022.1166. Welsh RC, Dehghani P, Lopes R, Wojdyla DM, Aronson R, Granger CB, Windecker S, Vora AN, Vinereanu D, Halvorsen S, Parkhomenko A, Mehran R, Alexander JH, Goodman S. Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial. Open Heart. 2022 Feb;9(1):e001892. doi: 10.1136/openhrt-2021-001892. Harskamp RE, Fanaroff AC, Lopes RD, Wojdyla DM, Goodman SG, Thomas LE, Aronson R, Windecker S, Mehran R, Granger CB, Alexander JH. Antithrombotic Therapy in Patients With Atrial Fibrillation After Acute Coronary Syndromes or Percutaneous Intervention. J Am Coll Cardiol. 2022 Feb 8;79(5):417-427. doi: 10.1016/j.jacc.2021.11.035. Hijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19. Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD. Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29. Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH. Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial. Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11. No abstract available. Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrom T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabate M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26. Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17. Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-Label, 2 x 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial. Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.
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Public notes
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Contacts
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/00/NCT02415400/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/00/NCT02415400/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02415400
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