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)

• Status: Completed
• Trial end date: 2002-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR); Dupont Applied Biosciences; LEO Pharma
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Warfarin

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