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:
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
  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
Detailed 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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Thromboembolism
Venous Thromboembolism
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 September 15, 2014