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)
The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.
Drug: Tinzaparin sodium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|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)|
- 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
|Study Start Date:||December 1994|
|Estimated Study Completion Date:||March 2002|
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.
|Thrombosis Research Unit, University of Calgary|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Russell D Hull, MBBS, MSc||University of Calgary|