Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00697099

Purpose

The primary objective of the study is to compare the efficacy of AVE5026 with enoxaparin for the prevention of venous thromboembolic events (VTE) in patients undergoing elective total hip replacement surgery.

The secondary objectives of this study are to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposures in this population.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: AVE5026 Drug: Enoxaparin	Phase III

Drug Information available for: Heparin Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Composite of any VTE and deaths from any cause [ Time Frame: From randomization up to the day of an event or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite of proximal deep vein thrombosis, symptomatic distal deep vein thrombosis, non fatal pulmonary embolism, all cause deaths [ Time Frame: From randomization up to the day of an event or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]
Safety: Bleeding, transfusions,laboratory data, adverse events, deaths [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2320
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AVE5026 once daily subcutaneous injection
2: Active Comparator	Drug: Enoxaparin once daily subcutaneous injection

Detailed Description:

The study treatments are administered for 7-10 days after surgery.

Eligibility

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

Criteria

Inclusion Criteria:

Elective total hip replacement surgery

Exclusion Criteria:

Any major orthopedic surgery in the 3 months prior to study start
Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome
Patients at high risk of bleeding
Known allergy to heparin - or enoxaparin
Any contra-indications to the performance of venography

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697099

Contacts

Contact: Public registry ICD

GV-Contact-us@sanofi-aventis.com

Show 21 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:	Patrick MOURET, MD	Orthopädische Klinik, Stätische Klinik, Gotenstrasse 6-8, Frankfurt Höechst, 65929 Frankfurt, Germany
Study Chair:	Alexander G. TURPIE, MD	HHS-General Hospital, Hamilton, Ontario, Canada

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10342, EudraCT 2007-007944-80
Study First Received:	June 12, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00697099
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

VTE prevention
Total Hip Replacement
Heparin Low-Molecular-Weight

Study placed in the following topic categories:

Body Weight
Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thromboembolism

Heparin
Thrombosis
Thromboembolism
Enoxaparin
Calcium heparin

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 January 15, 2009