Overview

This trial is active, not recruiting.

Conditions deep vein thrombosis, pulmonary embolism
Treatments discontinue anticoagulant therapy (negative d-dimer), continue on anticoagulant therapy (positive d-dimer)
Sponsor McMaster University
Collaborator Canadian Institutes of Health Research (CIHR)
Start date September 2008
End date May 2016
Trial size 410 participants
Trial identifier NCT00720915, CTMG-2007-DODS

Summary

The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
No Anticoagulant Therapy
discontinue anticoagulant therapy (negative d-dimer)
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
(Other)
Continue on anticoagulant therapy
continue on anticoagulant therapy (positive d-dimer)
Patients with positive d-dimer continue or re-start on anticoagulant therapy

Primary Outcomes

Measure
Suspected Recurrent DVT
time frame: up to 7 years
Suspected (recurrent) pulmonary embolism
time frame: up to 7 years
Bleeding
time frame: up to 7 years
Death
time frame: up to 7 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Be >= 18 years of age 2. Have had ONE episode of unprovoked proximal DVT and/or PE 3. Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0) Exclusion Criteria: 1. Another indication for long-term anticoagulation (e.g., atrial fibrillation) 2. A high risk of bleeding as evidenced by any of the following: - Age greater than 75 years - Previous episode of major bleeding where the cause was not effectively treated - Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L - Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl) - Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl) - Active peptic ulcer disease - Poor compliance with, or control of, anticoagulant therapy during initial treatment - Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel) 3. A vena caval filter 4. Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed 5. Has a life expectancy less than 5 years 6. Is unable to attend follow-up visits because of geographic inaccessibility 7. Is participating in a competing clinical investigation

Additional Information

Official title A Cohort Study to Test That There is a Low Risk of Recurrent VTE in Patients With a First Episode of Unprovoked VTE Who Stop Anticoagulant Therapy After 3 Months of Treatment in Response to Negative D-dimer Testing
Principal investigator Clive Kearon, MB MRCP(I) FRCP(C) PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by McMaster University.