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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Venous Thrombosis

Treatments: Drug: Apixaban; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633893

EUDRACT: 2007-004953-27

CV185-057

Details and patient eligibility

About

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Enrollment: 2,711 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women ≥ 18 years of age;
• Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
• Anticoagulant treatment completed
• No recurrence of Venous Thromboembolism (VTE)

Exclusion criteria

• Subjects with indications for long-term treatment with a vitamin K antagonist
• Active bleeding or high risk for serious bleeding
• Short life expectancy
• Uncontrolled high blood pressure
• Impaired kidney or liver function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,711 participants in 3 patient groups

1

Experimental group

Description:

2.5 mg

Treatment:

Drug: Apixaban

2

Experimental group

Description:

5.0 mg

Treatment:

Drug: Apixaban

3

Active Comparator group

Description:

0 mg

Treatment:

Drug: Placebo