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

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis and lung (pulmonary embolism 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.

Official Title

A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery

Conditions

• Deep Vein Thrombosis
• Pulmonary Embolism

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

• Primary Outcomes: A combination of asymptomatic and symptomatic DVT, non-fatal PE and all-cause death after 12 days of treatment
• Secondary Outcomes: The following combined endpoints after 12 days of treatment:; Proximal DVT, non-fatal PE, and all-cause death; Symptomatic DVT, non-fatal and fatal PE; Major and non-major bleeding events; Myocardial infarction and stroke

Study Start

November 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

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

Exclusion Criteria:

• hereditary or acquired bleeding disorders
• clotting disorders
• bleeding or high risk for bleeding
• drugs that affect bleeding or coagulation

Total Enrolment

3058 (expected)

Contact Details

• BMS Call Center 1-866-892-1BMS Ext. 407
• BMS Call Center Outside the US & Canada 1-941-906-4711 Ext. 407