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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndromes

Treatments: Drug: vitamin K antagonist; Drug: Apixaban; Drug: Acetylsalicylic acid; Other: Acetylsalicylic acid placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02415400

2014-002004-24 (EudraCT Number)

CV185-316

Details and patient eligibility

About

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.

Full description

Patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices.

Masking:

Apixaban: Open label.

VKA: Open label.

Acetylsalicylic acid film coated tablet: Double Blinded.

Placebo matching Acetylsalicylic acid film coated tablet: Double Blinded.

Enrollment: 4,614 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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4,614 participants in 4 patient groups, including a placebo group

Apixaban

Active Comparator group

Description:

5 mg or 2.5 mg Apixaban tablets orally twice per day

Treatment:

Drug: Apixaban

Vitamin K Antagonist

Active Comparator group

Description:

VKA tablets orally once daily

Treatment:

Drug: vitamin K antagonist

Acetylsalicylic acid film coated tablet

Placebo Comparator group

Description:

81 mg Acetylsalicylic acid film coated tablet orally once daily

Treatment:

Drug: Acetylsalicylic acid

Placebo matching Acetylsalicylic acid film coated tablet

Placebo Comparator group

Description:

Placebo matching Acetylsalicylic acid film coated tablet once daily

Treatment:

Other: Acetylsalicylic acid placebo