Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery (ADVANCE-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00452530
First received: March 23, 2007
Last updated: February 28, 2012
Last verified: February 2012
  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: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

Enrollment: 3054
Study Start Date: June 2007
Study Completion Date: January 2009
Primary Completion Date: January 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, 12 days
Other Name: Lovenox®
Experimental: A2
+ placebo
Drug: Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5mg, twice daily, 12 days
Other Name: BMS-562247

  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 total 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: NCT00452530

  Show 122 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: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00452530     History of Changes
Other Study ID Numbers: CV185-047, EUdraCT: 2006-006896-19
Study First Received: March 23, 2007
Last Updated: February 28, 2012
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 15, 2014