Dose Ranging Study in Elective Total Hip Replacement Surgery - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00338897

Purpose

The primary objective is to:

demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery.

The secondary objectives are to:

evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and
to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: SR123781A	Phase II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Double Dummy, Parallel Group, Dose Ranging Study of Subcutaneous SR123781A With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.

Secondary Outcome Measures:

Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration.

Enrollment:	1090
Study Start Date:	May 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed > 6 months prior to study entry

Exclusion Criteria:

Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization
Known progressive malignant disease
Ischemic stroke in the last 3 months
Myocardial infarction (MI) in the last 3 months
Any major orthopedic surgery in the 3 months prior to study start
Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments)
Treatment with other antithrombotic agents within 7 days prior to surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338897

Locations

Argentina, Buenos Aires
Sanofi-aventis
San Isidro, Buenos Aires, Argentina, 1642
Bulgaria
Sanofi-aventis
Sofia, Bulgaria, 1715
Chile, Santiago
Sanofi-aventis
Providencia, Santiago, Chile
Colombia
Sanofi-aventis
Santafe de Bogota, Colombia
Czech Republic
Sanofi-aventis
Praha, Czech Republic, 160 00
Denmark
Sanofi-aventis
Denmark, Denmark
Finland
Sanofi-aventis
Helsinki, Finland
Mexico
Sanofi-aventis
Mexico, Mexico, 04000
Norway
Sanofi-aventis
Oslo, Norway
Poland
Sanofi-aventis
Warszawa, Poland
Romania
Sanofi-aventis
Bucuresti, Romania, 70334
Russian Federation
Sanofi-aventis
Moscow, Russian Federation, 101000
Sweden
Sanofi-aventis
Bromma, Sweden
Turkey
Sanofi-aventis
Istanbul, Turkey, 34394

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Chair:

Michael Rud Lassen, MD

Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lassen MR, Dahl O, Mismetti P, Zielske D, Turpie AG. SR123781A: a new once-daily synthetic oligosaccharide anticoagulant for thromboprophylaxis after total hip replacement surgery: the DRIVE (Dose Ranging Study in Elective Total Hip Replacement Surgery) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1498-504.

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI5664, EudraCT : 2006-000152-41
Study First Received:	June 19, 2006
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00338897 History of Changes
Health Authority:	Russia: Pharmacological Committee, Ministry of Health; Romania: National Medicines Agency; Turkey: Ethics Committee

Keywords provided by Sanofi-Aventis:

Venous Thromboembolism
Prevention
Arthroplasty

Replacement
Hip
orthopedic surgery

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

Venous Thromboembolism
Thrombosis
Thromboembolism

ClinicalTrials.gov processed this record on November 20, 2009