Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism
NCT ID: NCT00967304
Last Updated: 2016-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2779 participants
INTERVENTIONAL
2008-11-30
2016-07-31
Brief Summary
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Detailed Description
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In the REVERSE I study, a clinical decision rule derivation study conducted from 2001 to 2006, we developed and internally validated the clinical decision rule "Men continue and HER DOO2" that identifies patients with a first unprovoked VTE who likely have a low risk of recurrent VTE and could safely discontinue OAT subsequent to 5-7 months of OAT. The present study will evaluate if the "Men continue and HER DOO2" rule (comprised of gender, elevated D-dimer levels, post-thrombotic signs, obesity, and older age) is safe, clinically useful, and reproducible when prospectively implemented in multiple centers and a variety of settings. If this clinical decision rule is validated, it will provide physicians with important information to allow them to more confidently identify unprovoked VTE patients at low risk of VTE recurrence who may not need to continue OAT.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1 Discontinue OAT or AAA
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3% per year); anticoagulant therapy will be withdrawn and the participant will then be followed for 1 year for any VTE recurrence and/or bleeding.
Application of the"Men continue and HER DOO2" rule
Consecutive patients will have the"Men continue and HER DOO2" rule applied by the attending physician between 5 - 12 months after treatment for a first unprovoked objectively proven major VTE.
"Men continue and HER DOO2" rule: all men continue oral anticoagulants and women with 2 or more of the following features after 5-7 months of OAT should continue oral anticoagulants:1) HER - any Hyperpigmentation, Edema and Redness of either lower extremity, 2) Vidas D-dimer ≥250ug/L, 3) Obesity - BMI ≥30 kg/m2 and 4) Older age - Age ≥65 years.
2 Observation arm
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.
No interventions assigned to this group
Interventions
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Application of the"Men continue and HER DOO2" rule
Consecutive patients will have the"Men continue and HER DOO2" rule applied by the attending physician between 5 - 12 months after treatment for a first unprovoked objectively proven major VTE.
"Men continue and HER DOO2" rule: all men continue oral anticoagulants and women with 2 or more of the following features after 5-7 months of OAT should continue oral anticoagulants:1) HER - any Hyperpigmentation, Edema and Redness of either lower extremity, 2) Vidas D-dimer ≥250ug/L, 3) Obesity - BMI ≥30 kg/m2 and 4) Older age - Age ≥65 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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BioMérieux
INDUSTRY
Centre Hospitalier Régional et Universitaire de Brest
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Marc Rodger, MD, MSc
Role: STUDY_CHAIR
Ottawa Hospital Research Institute
Locations
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UC Davis
Santa Monica, California, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Duke University
Durham, North Carolina, United States
Prince of Wales Hospital
Sydney, New South Wales, Australia
CUB Hopital Erasme
Brussels, , Belgium
CDHA-Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Center
Hamilton, Ontario, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Victoria Hospital
London, Ontario, Canada
Ottawa Health Research Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
SMBD Jewish General Hospital
Montreal, Quebec, Canada
Hopital Sacre Coeur
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
St. Mary's Hospital - CHUM
Montreal, Quebec, Canada
Hopital Enfant Jesus
Québec, Quebec, Canada
Saskatchewan Drug Research Institute
Saskatoon, Saskatchewan, Canada
Centre Hospitalier Regional Universitaire de Brest
Brest, , France
Orange Lifesciences
Nirmaya, , India
Sahyadri Speciality Hospital
Pune, , India
Shefali Centre
Shefali, , India
Jashvant Patel Clinic
Surat, , India
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Countries
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References
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Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008 Aug 26;179(5):417-26. doi: 10.1503/cmaj.080493.
Rodger MA, Le Gal G, Anderson DR, Schmidt J, Pernod G, Kahn SR, Righini M, Mismetti P, Kearon C, Meyer G, Elias A, Ramsay T, Ortel TL, Huisman MV, Kovacs MJ; REVERSE II Study Investigators. Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study. BMJ. 2017 Mar 17;356:j1065. doi: 10.1136/bmj.j1065.
Other Identifiers
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2008039-01H
Identifier Type: -
Identifier Source: org_study_id
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