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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00423319
First received: January 17, 2007
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  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 hip 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, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery

Resource links provided by NLM:

U.S. FDA Resources

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 35 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined endpoints: Proximal DVT, non-fatal PE, and VTE-related death [ Time Frame: after 35 days of treatment ] [ Designated as safety issue: No ]
  • Major & non-major bleeding events [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5406
Study Start Date: March 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1
+ placebo
 Drug: Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 5 weeks
Other Name: Lovenox®
Experimental: A2
+ placebo
 Drug: Apixaban + Placebo
Tablet + Syringes, Oral + Subcutaneous, 2.5 mg, twice daily, 5weeks
Other Names:
  • BMS-562247
  • Lovenox®

  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 hip 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: NCT00423319

  Show 143 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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: NCT00423319     History of Changes
Other Study ID Numbers: CV185-035
Study First Received: January 17, 2007
Last Updated: September 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prevention of deep vein thrombosis and
pulmonary embolism after total hip 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 May 19, 2013