Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00452530

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Deep Vein Thrombosis Knee Replacement Pulmonary Embolism Surgery

Drug Information available for: Apixaban Enoxaparin Sodium

U.S. FDA Resources

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
A1: Active Comparator + placebo	Drug: Enoxaparin + Placebo Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 12 days
A2: Experimental + placebo	Drug: Apixaban + Placebo Tablet + Syringes, Oral + subcutaneous, 2.5mg, twice daily, 12 days

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

Locations

India
Local Institution
Mangalore, India, 575001
Local Institution
Baroda, India, 390007
India, Gujarat
Local Institution
Ahmedabad, Gujarat, India, 380054

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV185-047, EUdraCT: 2006-006896-19
Study First Received:	March 23, 2007
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00452530 History of Changes
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

Study placed in the following topic categories:

Pulmonary Embolism
Anticoagulants
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis
Enoxaparin

Embolism and Thrombosis
Fibrin Modulating Agents
Respiratory Tract Diseases
Embolism
Lung Diseases
Venous Thrombosis

Additional relevant MeSH terms:

Pulmonary Embolism
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Thrombosis

Enoxaparin
Fibrin Modulating Agents
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009