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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)

Primary Purpose

Thrombosis, Thromboembolism, Venous Thrombosis

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Tinzaparin sodium

About this trial

This is an interventional treatment trial for Thrombosis focused on measuring venous thromboembolism, low-molecular-weight heparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Thrombosis Research Unit, University of Calgary

Outcomes

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

Full Information

NCT ID

NCT00203580

First Posted

September 12, 2005

Last Updated

February 8, 2007

Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR), LEO Pharma, Dupont Applied Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT00203580

Brief Title

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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

December 1994 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR), LEO Pharma, Dupont Applied Biosciences

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombosis, Thromboembolism, Venous Thrombosis

Keywords

venous thromboembolism, low-molecular-weight heparin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Masking

None (Open Label)

Allocation

Randomized

Enrollment

910 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tinzaparin sodium

Primary Outcome Measure Information:

Title

objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period

Title

death during initial treatment or during the 12 week follow-up period

Title

safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval

Secondary Outcome Measure Information:

Title

recurrent venous thromboembolism at 12 months

Title

death at 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Russell D Hull, MBBS, MSc

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thrombosis Research Unit, University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

8594426

Citation

Koopman MM, Prandoni P, Piovella F, Ockelford PA, Brandjes DP, van der Meer J, Gallus AS, Simonneau G, Chesterman CH, Prins MH. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. The Tasman Study Group. N Engl J Med. 1996 Mar 14;334(11):682-7. doi: 10.1056/NEJM199603143341102. Erratum In: N Engl J Med 1997 Oct 23;337(17):1251.

Results Reference

background

PubMed Identifier

8594425

Citation

Levine M, Gent M, Hirsh J, Leclerc J, Anderson D, Weitz J, Ginsberg J, Turpie AG, Demers C, Kovacs M. A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med. 1996 Mar 14;334(11):677-81. doi: 10.1056/NEJM199603143341101.

Results Reference

background

PubMed Identifier

1929681

Citation

Lancaster TR, Singer DE, Sheehan MA, Oertel LB, Maraventano SW, Hughes RA, Kistler JP. The impact of long-term warfarin therapy on quality of life. Evidence from a randomized trial. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. Arch Intern Med. 1991 Oct;151(10):1944-9. Erratum In: Arch Intern Med 1992 Apr;152(4):825.

Results Reference

background

PubMed Identifier

7168798

Citation

Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.

Results Reference

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Learn more about this trial

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)

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