NCT02415400

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,614 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Coronary Syndromes

Interventions

Type	Name	Description
DRUG	Apixaban
DRUG	vitamin K antagonist
DRUG	Acetylsalicylic acid
OTHER	Acetylsalicylic acid placebo

Timeline

• Start date: 2015-06-04
• Primary completion: 2018-11-10
• Completion: 2018-11-10
• First posted: 2015-04-14
• Last updated: 2020-06-11
• Results posted: 2020-02-07

Locations

626 sites across 37 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Ukraine, United Kingdom, Virgin Islands

Regulatory

• FDA-regulated drug study