Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism (REVERSEII)
Idiopathic Venous Thromboembolism
About this trial
This is an interventional diagnostic trial for Idiopathic Venous Thromboembolism focused on measuring Unprovoked Venous thromboembolism, Clinical decision rule, Anticoagulants, Recurrence, Prognostic, Risk stratification
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- UC Davis
- Penobscot Bay Medical Center
- Duke University
- Prince of Wales Hospital
- CUB Hopital Erasme
- CDHA-Queen Elizabeth II Health Science Centre
- Hamilton Health Sciences Center
- Hamilton Health Sciences Corporation
- Victoria Hospital
- Ottawa Health Research Institute
- University Health Network
- SMBD Jewish General Hospital
- Hopital Sacre Coeur
- McGill University Health Centre
- St. Mary's Hospital - CHUM
- Saskatchewan Drug Research Institute
- Hopital Enfant Jesus
- Centre Hospitalier Regional Universitaire de Brest
- Orange Lifesciences
- Sahyadri Speciality Hospital
- Shefali Centre
- Jashvant Patel Clinic
- Hopitaux Universitaires de Geneve
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
1 Discontinue OAT or AAA
2 Observation arm
Patients classified as being at low risk of recurrent VTE by the "HER DOO2"rule. If the clinical decision rule indicates that a patient is at low recurrence risk (<3% per year); anticoagulant therapy will be withdrawn and the participant will then be followed for 1 year for any VTE recurrence and/or bleeding.
Men and patients classified as being at high risk of recurrent VTE by the "HER DOO2"rule. If the clinical decision rule indicates that a patient is at high recurrence risk then the decision to continue or discontinue anticoagulant therapy will be left to the discretion of physicians and patients as per current standard of care and this decision recorded. High risk patients (females classified as being at high risk of recurrent VTE by the CDR, and all males) will then be followed as an observational cohort for 1 year for any VTE recurrence and/or bleeding.