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 Squibb4,614 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

4,614

Conditions

Acute Coronary Syndromes

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (626)

Cardiovascular Associates of the Southeast, LLC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Heart Rhythm Center

Phoenix, Arizona, United States

Local Institution

Phoenix, Arizona, United States

Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period

Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.