Status:
COMPLETED
Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
BioMérieux
Centre Hospitalier Régional et Universitaire de Brest
Conditions:
Idiopathic Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral ant...
Detailed Description
Up to 50% of patients with a first episode of venous thromboembolism (VTE) have no identifiable cause (i.e. are unprovoked VTEs). The risk of recurrent VTE in this large group of patients with unprovo...
Eligibility Criteria
Inclusion
- First episode of major unprovoked VTE
- VTE objectively proven
- VTE treated for 5-12 months with anticoagulant therapy authorized for the REVERSE II study (initial or ongoing therapy)
- Absence of recurrent VTE during the treatment period
Exclusion
- Less than 18 years of age
- Patients who have already discontinued anticoagulant therapy
- Patients requiring ongoing anticoagulation for reasons other than VTE
- Being treated for a recurrent unprovoked VTE
- Patients with high risk thrombophilia
- patients who plan on using exogenous estrogen(OCP,HRT)if anticoagulant therapy is discontinued
- Patients with pregnancy associated VTE
- Geographically inaccessible for follow-up
- Patients unable or unwilling to provide informed consent
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
2779 Patients enrolled
Trial Details
Trial ID
NCT00967304
Start Date
November 1 2008
End Date
July 1 2016
Last Update
September 1 2016
Active Locations (23)
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1
UC Davis
Santa Monica, California, United States
2
Penobscot Bay Medical Center
Rockport, Maine, United States
3
Duke University
Durham, North Carolina, United States, 27705
4
Prince of Wales Hospital
Sydney, New South Wales, Australia