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Ultrasound Findings to Adjust the Duration of Anticoagulation

NCT00380120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2008-03-18

No results posted yet for this study

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.

Conditions

  • Deep Vein Thrombosis

Interventions

DRUG

sodium warfarin

dosage: as much as it is required to prolong the international normalized ratio, checked every 2-3 weeks, between 2.0 and 3.0

DRUG

Sodium warfarin

As much drug as it is necessary to prolong the international normalized ratio between 2.0 and 3.0

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Paolo Prandoni, MD, PhD · Department of Medical and Surgical Sciences, University of Padua, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2003-06-30
Completion
2006-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00380120 on ClinicalTrials.gov