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 and/or Percutaneous Coronary Intervention.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 250

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 for at least 6 months AND
b) 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 the 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).

Exclusion Criteria

- 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints (safety):<br /><br>The primary endpoint for apixaban versus VKA is<br /><br>* ISTH major or CRNM bleeding<br /><br>The primary endpoint for aspirin versus placebo is<br /><br>* ISTH major or CRNM bleeding</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>The secondary endpoint for apixaban versus VKA includes<br /><br>* Superiority on major or CRNM bleeding<br /><br>* Superiority for the composite of all-cause death/all-cause<br /><br>rehospitalization.<br /><br>The composite endpoints of death, stroke, myocardial infarction, stent<br /><br>thrombosis, urgent coronaire revascularization<br /><br> First re-hospitalization for any cause<br /><br>The secondary endpoint for aspirin versus placebo includes<br /><br>* The composite endpoints of death, stroke, myocardial infarction, stent<br /><br>thrombosis, urgent coronaire revascularization<br /><br>* First re-hospitalization for any cause</p><br>