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

Completed · Phase 4

Conditions studied: Idiopathic Venous Thromboembolism

In brief

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.

Key facts

Study ID

NCT00967304

Run by

Ottawa Hospital Research Institute

People needed

2779

Starts

2008-11-01

Expected to finish

2016-07-01

Last updated by the study team

2016-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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