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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00371683
First received: August 30, 2006
Last updated: September 10, 2010
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Enoxaparin + Placebo
Drug: Apixaban + Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • A combination of asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The following combined endpoints: [ Time Frame: after 12 days of treatment ]
  • Proximal DVT, non-fatal PE, and all-cause death [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: No ]
  • Symptomatic DVT, non-fatal and fatal PE [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: No ]
  • Major and non-major bleeding events [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: Yes ]
  • Myocardial infarction and stroke [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 3202
Study Start Date: November 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1
+ placebo
Drug: Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
Other Name: Lovenox®
Experimental: A2
+ placebo
Drug: Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371683

  Show 107 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00371683     History of Changes
Other Study ID Numbers: CV185-034
Study First Received: August 30, 2006
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 20, 2014