- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00203580
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)
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 Overview
Status
Conditions
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
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- Thrombosis Research Unit, University of Calgary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Russell D Hull, MBBS, MSc, University of Calgary
Publications and helpful links
General Publications
- Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2736-1
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.
Clinical Trials on Thrombosis
-
Università degli Studi dell'InsubriaOttawa Hospital Research InstituteUnknownPortal Vein Thrombosis | Mesenteric Vein Thrombosis | Splenic Vein ThrombosisCanada, Italy
-
University of MaltaUniversità degli Studi dell'InsubriaRecruitingCerebral Vein Thrombosis | Renal Vein Thrombosis | Retinal Vein Thrombosis | Splanchnic Vein Thrombosis | Ovarian Vein ThrombosisThailand, Spain, United States, Italy, Slovenia, France, Israel, Canada, Malta, Netherlands
-
Capital Medical UniversityBeijing Municipal Science & Technology CommissionNot yet recruitingCerebral Venous Sinus Thrombosis | Deep Cerebral Vein Thrombosis | Cortical Vein Thrombosis
-
University of AlbertaSanofi; Edmonton Civic Employees Research FundTerminatedPortal Vein Thrombosis | Splenic Vein ThrombosisCanada
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)CompletedDeep Vein Thrombosis | Venous Thromboembolism | Pulmonary Embolism | Malignant Neoplasm | Portal Vein Thrombosis | Metastatic Malignant Neoplasm | Cerebral Vein Thrombosis | Renal Vein Thrombosis | Gonadal Thrombosis | Hepatic Thrombosis | Mesenteric Thrombosis | Splenic ThrombosisUnited States
-
Assiut UniversityNot yet recruitingPortal Vein Thrombosis
-
Azienda Ospedaliera Universitaria PoliclinicoCompletedDeep Vein ThrombosisItaly
-
Instituto Nacional de Ciencias Medicas y Nutricion...RecruitingPortal Vein ThrombosisMexico
-
Nihon Pharmaceutical Co., LtdCompletedPortal Vein ThrombosisJapan
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceCompleted
Clinical Trials on Tinzaparin sodium
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, France; National Cancer Institute, FranceTerminatedVenous Thromboembolism | Lung NeoplasmFrance
-
University of VermontNational Cancer Institute (NCI)UnknownKidney CancerUnited States
-
University of Southern CaliforniaCelgene CorporationTerminatedCancer | Venous ThromboembolismUnited States
-
University of CalgaryCanadian Institutes of Health Research (CIHR); LEO Pharma; Dupont Applied BiosciencesCompletedThrombosis | Venous Thrombosis | ThromboembolismCanada
-
Imperial College LondonRecruitingVaricose Veins | Venous ThromboembolismUnited Kingdom
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Netherlands Organisation for Scientific Research; Aspen Pharma; CHU of Saint... and other collaboratorsCompletedPulmonary Embolism | Deep Venous ThrombosisNorway, Netherlands, Denmark, France, Belgium, Ireland, United States, Canada, Russian Federation, Spain
-
Assistance Publique - Hôpitaux de ParisCompletedLung Cancer | Non Small Cell Lung CancerFrance
-
University of AarhusAarhus University Hospital; LEO PharmaCompletedFetal Growth RetardationDenmark
-
Tampere University HospitalRecruitingAcute Kidney Injury | Renal Replacement Therapy | AnticoagulantsFinland
-
PfizerCompletedDiabetic Foot UlcerCanada, Greece, Austria, Finland, Poland, Sweden, Russian Federation, Norway, Spain, Italy, United Kingdom, Denmark, Lithuania, Belgium, Germany, Ukraine, Czechia