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Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism (REVERSEII)

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ClinicalTrials.gov Identifier: NCT00967304
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : September 1, 2016
Sponsor:
Collaborators:
BioMérieux
Centre Hospitalier Régional et Universitaire de Brest
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Idiopathic Venous Thromboembolism Other: Application of the"Men continue and HER DOO2" rule Phase 4

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 unprovoked VTE after 3-6 months of anticoagulant therapy is 5-10.8% in the year following discontinuation of oral anticoagulant therapy. One in six to one in twenty recurrences of a new VTE are fatal. Given the intermediate risks of recurrence in unselected unprovoked VTE patients, clinicians do not have clear guidance on whether to continue or discontinue anticoagulants in patients with unprovoked VTE. Recently attention has turned to the concept of risk stratification to identify subgroups of patients with unprovoked VTE who could safely discontinue oral anticoagulation therapy (OAT).

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2779 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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.
Study Start Date : November 2008
Actual Primary Completion Date : January 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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.

Other: 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 Name: Clinical Decision Rule

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.




Primary Outcome Measures :
  1. 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. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Any VTE 1 year event rate in low risk patients [ Time Frame: One year ]
  2. Major bleeding 1 year event rate in un-anticoagulated low risk patients [ Time Frame: One year ]
  3. Major VTE 1 year event rate in high risk patients who continue anticoagulant therapy [ Time Frame: One year ]
  4. Major VTE 1 year event rate in high risk patients who discontinue anticoagulant therapy [ Time Frame: One year ]
  5. Major Bleeding 1 year event rate in high risk patients [ Time Frame: One year ]
  6. Clinical utility of the rule [ Time Frame: One year ]
  7. Inter-observer reliability of the clinical decision rule [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967304


Locations
Show Show 23 study locations
Sponsors and Collaborators
Ottawa Hospital Research Institute
BioMérieux
Centre Hospitalier Régional et Universitaire de Brest
Investigators
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Study Chair: Marc Rodger, MD, MSc Ottawa Hospital Research Institute

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00967304    
Other Study ID Numbers: 2008039-01H
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Keywords provided by Ottawa Hospital Research Institute:
Unprovoked Venous thromboembolism
Clinical decision rule
Anticoagulants
Recurrence
Prognostic
Risk stratification
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anticoagulants