Phase III Acute Coronary Syndrome (APPRAISE-2)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Drug: Placebo; Drug: Apixaban

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00831441

CV185-068

EUDRACT# 2008-008298-77

Details and patient eligibility

About

The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome

Enrollment: 7,484 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute coronary syndrome (ACS)
• Clinically stable
• Receiving standard of care for ACS

Exclusion criteria

• Severe hypertension
• Active bleeding or high risk for major bleeding
• Hemoglobin < 9 g/dL

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7,484 participants in 2 patient groups, including a placebo group

Apixaban

Active Comparator group

Treatment:

Drug: Apixaban

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo