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)
This study has been completed.
Sponsor:
University of Calgary
Collaborators:
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Dupont Applied Biosciences
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00203580
First received: September 12, 2005
Last updated: February 8, 2007
Last verified: September 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombosis Thromboembolism Venous Thrombosis |
Drug: Tinzaparin sodium |
Phase 4 |
| Study Type: | Interventional |
| 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) |
Resource links provided by NLM:
Further study details as provided by University of Calgary:
Primary Outcome Measures:
- 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:
- recurrent venous thromboembolism at 12 months
- death at 12 months
| Estimated Enrollment: | 910 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203580
Locations
| Canada, Alberta | |
| Thrombosis Research Unit, University of Calgary | |
| Calgary, Alberta, Canada, T2N 2T9 | |
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Dupont Applied Biosciences
Investigators
| Principal Investigator: | Russell D Hull, MBBS, MSc | University of Calgary |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00203580 History of Changes |
| Other Study ID Numbers: | 2736-1 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 8, 2007 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by University of Calgary:
|
venous thromboembolism low-molecular-weight heparin |
Additional relevant MeSH terms:
|
Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Heparin Heparin, Low-Molecular-Weight Dalteparin |
Tinzaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013