Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery (TREK) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00331838

Purpose

The primary objective is to demonstrate the efficacy of AVE5026 for prevention of Venous Thromboembolism (VTE) in patients undergoing elective Total Knee Replacement (TKR) surgery.

The secondary objectives are to evaluate the safety (incidence of major bleeding)of AVE5026 and to assess the pharmacokinetic parameters of AVE5026

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

MedlinePlus related topics: Deep Vein Thrombosis Knee Replacement

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose Response Study of SC AVE5026 With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The primary efficacy endpoint is a composite endpoint 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 first study drug injection up to 3 calendar days after last study drug injection.

Estimated Enrollment:	800
Study Start Date:	May 2006
Study Completion Date:	June 2007

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 knee replacement or a revision of a primary procedure performed ≥ 6 months prior to study entry

Exclusion Criteria:

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 known post-phlebitic syndrome
Known sensitivity to iodine or contrast dyes
Recent stroke or myocardial infarction
Patients at high risk of bleeding
Treatment with other anti-thrombotic agents within 7 days prior to surgery
Any contra-indication to UFH or LMWH
Pregnant or nursing woman, or women of childbearing potential who are not using an effective contraceptive method.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331838

Show 19 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Chair:

Michael LASSEN, MD

Hoersholm Hospital (Denmark)

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	DRI6243, AVE5026
Study First Received:	May 18, 2006
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00331838
Health Authority:	Denmark: Danish Medicines Agency; Spain: Spanish Agency of Medicines; Poland: Ministry of Health

Keywords provided by Sanofi-Aventis:

Prevention
Venous Thrombosis
Orthopedic Surgery

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thrombosis

Venous Thromboembolism
Thromboembolism
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009