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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00967304




Registration number
NCT00967304
Ethics application status
Date submitted
26/08/2009
Date registered
27/08/2009
Date last updated
1/09/2016

Titles & IDs
Public title
Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism
Scientific title
REVERSEII: Validation of the "Men and HERDOO2"- A Clinical Decision Rule to Identify Patients With "Unprovoked" Venous Thromboembolism Who Can Discontinue Anticoagulants After 6 Months of Treatment.
Secondary ID [1] 0 0
2008039-01H
Universal Trial Number (UTN)
Trial acronym
REVERSEII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Application of the"Men continue and HER DOO2" rule

Experimental: 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3% per year); anticoagulant therapy will be withdrawn and the participant will then be followed for 1 year for any VTE recurrence and/or bleeding.

No intervention: 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.


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary study outcome is the incidence of adjudicated recurrent major VTE at 1 year in patients deemed by the "Men and HER DOO2" CDR to be at low risk of recurrent VTE.
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
Any VTE 1 year event rate in low risk patients
Timepoint [1] 0 0
One year
Secondary outcome [2] 0 0
Major bleeding 1 year event rate in un-anticoagulated low risk patients
Timepoint [2] 0 0
One year
Secondary outcome [3] 0 0
Major VTE 1 year event rate in high risk patients who continue anticoagulant therapy
Timepoint [3] 0 0
One year
Secondary outcome [4] 0 0
Major VTE 1 year event rate in high risk patients who discontinue anticoagulant therapy
Timepoint [4] 0 0
One year
Secondary outcome [5] 0 0
Major Bleeding 1 year event rate in high risk patients
Timepoint [5] 0 0
One year
Secondary outcome [6] 0 0
Clinical utility of the rule
Timepoint [6] 0 0
One year
Secondary outcome [7] 0 0
Inter-observer reliability of the clinical decision rule
Timepoint [7] 0 0
One year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
Accrual to date
Final
2779
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maine
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
India
State/province [10] 0 0
Nirmaya
Country [11] 0 0
India
State/province [11] 0 0
Pune
Country [12] 0 0
India
State/province [12] 0 0
Shefali
Country [13] 0 0
India
State/province [13] 0 0
Surat
Country [14] 0 0
Switzerland
State/province [14] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Hospital Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
BioMérieux
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Centre Hospitalier Régional et Universitaire de Brest
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 anticoagulant therapy after 5-7 months of treatment.
Trial website
https://clinicaltrials.gov/study/NCT00967304
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Marc Rodger, MD, MSc
Address 0 0
Ottawa Hospital Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00967304