A non-blinded (i.e., open-label), randomized clinical trial to evaluate the safety of Apixaban (Eliquis®=BMS oral anticoagulant) vs. Coumadin [=vitamin K antagonist (VKA)} and blinded Aspirin vs. Aspirin Placebo in patients with atrial fibrillation (not related to a heart valve problem or nonvalvular AF = NVAF) and heart attacks (i.e., ACS = Acute Coronary Syndrome) with a coronary stent placement (PCI = percutaneous coronary intervention) OR after having elective PCI for chest pain.
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary InterventionMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10065608Term: Percutaneous coronary interventionSystem Organ Class: 10042613 - Surgical and medical procedures
- Registration Number
- EUCTR2014-002004-24-BG
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4600
1. Signed Written Informed Consent
a) Subjects will be required to provide a written informed consent.
2. Target Population
a) Males and females 18 years of age (or age of majority) or older 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 for at least 6 months AND
b) Must have had an acute coronary syndrome (ST-elevation myocardial infarction
[STEMI], non-ST-elevation myocardial infarction [NSTEMI], or unstable angina), within
the prior 14 days with planned use of an approved P2Y12 inhibitor for at least 6 months
AND/OR
c) PCI (with or without stents) within the prior 14 days with planned use of an approved P2Y12 inhibitor for at least 6 months.
( If both an ACS event and an elective PCI occur within the same 14 day period, the investigator has the option to define index event for the randomization to the interactive voice/web response system. It is recommended to choose the most recent event as the index event.
However, for the electronic case report form, if a patient has both an ACS and PCI within 14 days, both events can be selected.)
3. Subject Re-enrollment:
a) This study does permit the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (screen failure).
4. Age and Reproductive Status
a) Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within
24 hours prior to the start of study drug.
b) Women must not be breastfeeding
c) WOCBP must agree to use effective contraception for the duration of treatment with study drugs plus
i. 33 days for patients on apixaban
ii. 40 days for patients on warfarin
d) Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in this section.
Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1978
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2622
- Conditions other than atrial fibrillation that require chronic anticoagulation (eg, prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL [133 micromol/L] or a calculated creatinine clearance < 30 mL/min
- Patients with any history of intracranial hemorrhage
- Any contraindications to warfarin, apixaban, to intended P2Y12 inhibitors or to aspirin
- Patients who have or will undergo coronary arterial bypass graft (CABG) for their index
ACS event
- Patients with known ongoing bleeding
- Patients with known coagulopathies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method