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

NCT00967304 | Completed Phase 4 DMC

• 1 other identifier: 2008039-01H
• Study Type: interventional
• Target: 2,779
• Locations: 7 countries
• Sites: 23

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.

Conditions

Idiopathic Venous Thromboembolism

Keywords

Unprovoked Venous thromboembolism; Clinical decision rule; Anticoagulants; Recurrence; Prognostic; Risk stratification

Outcome Measures

Primary Outcomes (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.

  One year

Secondary Outcomes (7)

• Any VTE 1 year event rate in low risk patients

  One year

• Major bleeding 1 year event rate in un-anticoagulated low risk patients

  One year

• Major VTE 1 year event rate in high risk patients who continue anticoagulant therapy

  One year

• Major VTE 1 year event rate in high risk patients who discontinue anticoagulant therapy

  One year

• Major Bleeding 1 year event rate in high risk patients

  One year

Study Arms (2)

1 Discontinue OAT or AAA

EXPERIMENTAL

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3% per year); anticoagulant therapy will be withdrawn and the participant will then be followed for 1 year for any VTE recurrence and/or bleeding.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

2 Observation arm

NO INTERVENTION

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.

Interventions

Application of the"Men continue and HER DOO2" rule OTHER

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.

Also known as: Clinical Decision Rule

1 Discontinue OAT or AAA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• BioMérieux: collaborator
• Centre Hospitalier Régional et Universitaire de Brest: collaborator

Study Sites (23)

UC Davis

Santa Monica, California, United States

Location

Penobscot Bay Medical Center

Rockport, Maine, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Prince of Wales Hospital

Sydney, New South Wales, Australia

Location

CUB Hopital Erasme

Brussels, Belgium

Location

CDHA-Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, B3H2Y9, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Location

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Location

Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

Ottawa Health Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

SMBD Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hopital Sacre Coeur

Montreal, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

St. Mary's Hospital - CHUM

Montreal, Quebec, Canada

Location

Hopital Enfant Jesus

Québec, Quebec, Canada

Location

Saskatchewan Drug Research Institute

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Centre Hospitalier Regional Universitaire de Brest

Brest, France

Location

Orange Lifesciences

Nirmaya, India

Location

Sahyadri Speciality Hospital

Pune, India

Location

Shefali Centre

Shefali, India

Location

Jashvant Patel Clinic

Surat, India

Location

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 18725614 BACKGROUND

• 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.

  PMID: 28314711 DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

Clinical Decision Rules

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decision Support Techniques; Investigative Techniques

Study Officials

• Marc Rodger, MD, MSc

  Ottawa Hospital Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

IN (4); AU (1); CH (1); BE (1); CA (12); FR (1); US (3)