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.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 4600

Inclusion Criteria

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.
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
c) Planned use of an approved P2Y12 inhibitor for at least 6 months.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

Exclusion Criteria

- Conditions other than atrial fibrillation that require chronic anticoagulation (eg, prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine > 2.5 [221 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