Status:
COMPLETED
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)
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Conditions:
Thrombosis
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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) v...
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 a...
Eligibility Criteria
Inclusion
- Patients having a first or recurrent episode of acute proximal vein thrombosis
Exclusion
- 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
Key Trial Info
Start Date :
December 1 1994
Trial Type :
INTERVENTIONAL
End Date :
March 1 2002
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT00203580
Start Date
December 1 1994
End Date
March 1 2002
Last Update
February 9 2007
Active Locations (1)
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1
Thrombosis Research Unit, University of Calgary
Calgary, Alberta, Canada, T2N 2T9