Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Venous Thrombosis

Treatments: Drug: Placebo for apixaban; Drug: warfarin; Drug: Placebo for enoxaparin; Drug: apixaban; Drug: Enoxaparin; Drug: Placebo for warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643201

CV185-056

EUDRACT: 2007-007867-25

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Enrollment: 5,614 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women ≥ 18 years of age
• Clinical diagnosis of DVT or PE

Exclusion criteria

• Contraindications for enoxaparin or warfarin
• Active bleeding or high risk for serious bleeding
• Short life expectancy
• Uncontrolled high blood pressure
• Significantly impaired kidney or liver function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5,614 participants in 2 patient groups

Apixaban

Active Comparator group

Description:

apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.

Treatment:

Drug: Placebo for apixaban

Drug: Enoxaparin

Drug: warfarin

Enoxaparin + Warfarin

Experimental group

Description:

Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.

Treatment:

Drug: Placebo for warfarin

Drug: Placebo for enoxaparin

Drug: apixaban