Safety Study of Apixaban in Recent Acute Coronary Syndrome

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome (ACS)

Treatments: Drug: Apixaban; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313300

CV185-023

Details and patient eligibility

About

The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.

Enrollment: 1,741 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Recent (< = 7 days) Acute Coronary Syndrome (ACS).
• Clinically stable on optimal treatment

Key Exclusion Criteria:

• High bleeding risk.
• Ongoing anticoagulant use.
• Need for chronic (>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (>325 mg/day

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,741 participants in 4 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: Apixaban

Drug: Apixaban

Drug: Apixaban

A2

Experimental group

Treatment:

Drug: Apixaban

Drug: Apixaban

Drug: Apixaban

A3

Placebo Comparator group

Treatment:

Drug: Placebo

A4

Experimental group

Treatment:

Drug: Apixaban

Drug: Apixaban

Drug: Apixaban