Please select the eligibility criteria that correspond to the clinical trial below.
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
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.


Options:
A: Inclusion Criteria:

* Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
* Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
* Need for continued anticoagulant therapy
* Significant renal impairment or known significant liver disease
B: Inclusion Criteria:

* Have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
* Have undergone percutaneous coronary intervention (PCI) procedure (with stent placement) for primary atherosclerotic disease
* Must have an international normalized ratio (INR) of 2.5 or below to be randomized
* Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active
* Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol

Exclusion Criteria:

* Have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count \<90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated prothrombin time (PT) at screening
* Have anemia of unknown cause with a hemoglobin level \<10 g/dL (\<6.21 mmol/L)
* Have a history of stroke or Transient Ischemic Attack (TIA)
* Have a calculated Creatinine Clearance (CrCl) \<30 mL/min at screening
* Have known significant liver disease or liver function test (LFT) abnormalities
* Have any severe condition that would limit life expectancy to less than 12 months
C: Inclusion Criteria:

* A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.
* A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
* If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

* A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
* A person who has active internal bleeding or has a history of a bleeding disorder.
* Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
* A person who has liver disease; for example, cirrhosis.
* A person who has a condition such as alcoholism, mental illness, or is drug dependent.
* A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).
D: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

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

Answer: D