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)

February 8, 2007 updated by: University of Calgary

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)

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

910

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Thrombosis Research Unit, University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
recurrent venous thromboembolism at 12 months
death at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Russell D Hull, MBBS, MSc, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1994

Study Completion

March 1, 2002

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 9, 2007

Last Update Submitted That Met QC Criteria

February 8, 2007

Last Verified

September 1, 2005

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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