Ultrasound Findings to Adjust the Duration of Anticoagulation

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis (DVT) of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a fixed duration of anticoagulant therapy (three months in patients with DVT secondary to transitory risk factors, six months in patients with idiopathic DVT) or a flexible duration of anticoagulant therapy, according to the persistence of residual thrombi, as shown by leg veins ultrasonography (up to 1 year in patients with secondary DVT, up to 2 years in those with idiopathic DVT). All patients are followed up to three years to assess the development of (objectively documented) recurrent thromboembolism. The rate of recurrent thromboembolism is compared between the two study groups, as well as the rate of major bleeding complications occurring during anticoagulation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Treatments: Warfarin

Criteria

Inclusion Criteria:

• acute proximal DVT associated or not with clinically symptomatic pulmonary embolism

Exclusion Criteria:

• history of previous VTE

• active cancer

• indications for permanent anticoagulation

• contraindications to anticoagulation

• pregnancy

• geographical inaccessibility for long-term follow-up

• life expectancy shorter than 1 year

• refusal of informed consensus