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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00371683
First received: August 30, 2006
Last updated: August 28, 2014
Last verified: August 2009

August 30, 2006
August 28, 2014
November 2006
May 2008   (final data collection date for primary outcome measure)
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 ]
A combination of asymptomatic and symptomatic DVT, non-fatal PE and all-cause death after 12 days of treatment
Complete list of historical versions of study NCT00371683 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Drug: Enoxaparin + Placebo
    Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
    Other Name: Lovenox®
  • Drug: Apixaban + Placebo
    Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
  • Active Comparator: A1
    + placebo
    Intervention: Drug: Enoxaparin + Placebo
  • Experimental: A2
    + placebo
    Intervention: Drug: Apixaban + Placebo
Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009 Aug 6;361(6):594-604.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3202
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Poland,   Turkey,   Sweden,   Russian Federation,   Argentina,   Australia,   Brazil,   Denmark,   Hungary,   Israel,   Mexico
 
NCT00371683
CV185-034
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP