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)

Thrombosis Clinical Trial

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)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thrombosis

• NCT number: NCT00203580
• Study type: Interventional
• Source: University of Calgary
• Status: Completed
• Phase: Phase 4
• Start date: December 1994
• Completion date: March 2002