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

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

MedlinePlus related topics:

Knee Replacement Pulmonary Embolism

ChemIDplus related topics:

Apixaban Enoxaparin Sodium

U.S. FDA Resources

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)

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 ]

Estimated Enrollment:	3058
Study Start Date:	June 2007
Estimated Study Completion Date:	January 2009
Estimated 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

Contacts


Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 144 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV185-047, EUdraCT: 2006-006896-19
First Received:	March 23, 2007
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00452530
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:

Embolism and Thrombosis

Pulmonary Embolism

Respiratory Tract Diseases

Embolism

Lung Diseases

Vascular Diseases

Venous Thrombosis

Thrombosis

Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2008

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