Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Treatments: Drug: Enoxaparin + Placebo; Drug: Apixaban + Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00371683

CV185-034

Details and patient eligibility

About

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Enrollment: 3,608 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Men and non-pregnant, non-breastfeeding women
• 18 years or older
• Scheduled for knee replacement surgery

Key Exclusion Criteria:

• hereditary or acquired bleeding disorders
• clotting disorders
• bleeding or high risk for bleeding
• drugs that affect bleeding or coagulation
• need for ongoing parenteral or oral anticoagulation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,608 participants in 2 patient groups

A1

Active Comparator group

Description:

+ placebo

Treatment:

Drug: Enoxaparin + Placebo

A2

Experimental group

Description:

+ placebo

Treatment:

Drug: Apixaban + Placebo