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)

Thrombosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203580
• Other study ID #: 2736-1
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 8, 2007
• Start date: December 1994
• Est. completion date: March 2002

Study information

• Verified date: September 2005
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 910
• Est. completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Tinzaparin sodium

Locations

Country	Name	City	State
Canada	Thrombosis Research Unit, University of Calgary	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR), Dupont Applied Biosciences, LEO Pharma

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. Erratum in: N Engl J Med 1997 Oct 23;337(17):1251. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
Primary	death during initial treatment or during the 12 week follow-up period
Primary	safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval
Secondary	recurrent venous thromboembolism at 12 months
Secondary	death at 12 months