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) - Full Text View

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 IV

MedlinePlus related topics:

Blood Thinners Deep Vein Thrombosis

Drug Information available for:

Warfarin Warfarin potassium Warfarin sodium Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control

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)

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

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 Pharmaceuticals

Investigators


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

More Information

Publications:

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.

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.

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.

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

Study ID Numbers:	2736-1
First Received:	September 12, 2005
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00203580
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by University of Calgary:

venous thromboembolism

low-molecular-weight heparin

Study placed in the following topic categories:

Heparin, Low-Molecular-Weight

Vascular Diseases

Warfarin

Venous Thromboembolism

Thrombosis

Thromboembolism

Calcium heparin

Body Weight

Embolism and Thrombosis

Embolism

Tinzaparin

Venous Thrombosis

Heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	University of Calgary Canadian Institutes of Health Research (CIHR) LEO Pharma Dupont Pharmaceuticals
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00203580