Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)
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|ClinicalTrials.gov Identifier: NCT00203580|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 9, 2007
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis Thromboembolism Venous Thrombosis||Drug: Tinzaparin sodium||Phase 4|
The accepted treatment for acute deep vein thrombosis (DVT) is initial continuous intravenous heparin followed by long-term oral anticoagulant therapy. Improvements in the methods of clinical trials and the use of accurate objective tests to detect venous thromboembolism have made it possible to perform a series of randomized trials to evaluate various treatments of venous thromboembolism.
The specific objectives of the Main LITE Study are:
- to determine if low-molecular-weight heparin, given subcutaneously once daily without laboratory monitoring, is more effective than adjusted oral warfarin sodium in the reduction of mortality rate.
- to determine if such a low-molecular-weight heparin therapy is more cost-effective than present standard care methods.
- to determine the incidence of Factor V Leiden and Prothrombin 20210A mutant genetic abnormalities.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||910 participants|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of the Effect of Low-Molecular-Weight Heparin Versus Warfarin Sodium on the Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (Main LITE Study)|
|Study Start Date :||December 1994|
|Estimated Study Completion Date :||March 2002|
- objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
- death during initial treatment or during the 12 week follow-up period
- safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval
- recurrent venous thromboembolism at 12 months
- death at 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203580
|Thrombosis Research Unit, University of Calgary|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Russell D Hull, MBBS, MSc||University of Calgary|