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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Thrombosis, Thromboembolism, Venous Thrombosis

Intervention / Treatment
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* Drug: Tinzaparin sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having a first or recurrent episode of acute proximal vein thrombosis Exclusion Criteria: Presence of familial bleeding diathesis or presence of active bleeding contraindicating anticoagulant therapy Receiving therapeutic heparin or therapeutic low-molecular-weight heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis Receiving long-term warfarin treatment Females who are pregnant Known allergy to heparin, warfarin sodium, or bisulfites History of heparin-associated thrombocytopenia Severe malignant hypertension Hepatic encephalopathy Severe renal failure Inability to attend follow-up due to geographic inaccessibility Inability or refusal to give informed consent Recent neurological or opthalmic surgery (within the previous 14 days) Pulmonary embolism requiring thrombolytic therapy, surgical thrombectomy, or vena cava interruption Life expectancy of less than 3 months Taking ASA prior to randomization and unable to discontinue this medication during the 84 day study treatment period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tinzaparin sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent venous thromboembolism at 12 months |  |  | 
| death at 12 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous thromboembolism, low-molecular-weight heparin