D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Pulmonary Embolism
• Interventions: Other: Continue on anticoagulant therapy (positive d-dimer); Other: Discontinue anticoagulant therapy (Negative d-dimer)

• Registration Number: NCT00720915
• Lead Sponsor: McMaster University

Brief Summary

The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-23
• Study Start: 2008-09
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

1. Be >= 18 years of age
2. Have had ONE episode of unprovoked proximal DVT and/or PE
3. Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)

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Exclusion Criteria

1. Another indication for long-term anticoagulation (e.g., atrial fibrillation)

2. A high risk of bleeding as evidenced by any of the following:

   • Age greater than 75 years
   • Previous episode of major bleeding where the cause was not effectively treated
   • Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L
   • Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl)
   • Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl)
   • Active peptic ulcer disease
   • Poor compliance with, or control of, anticoagulant therapy during initial treatment
   • Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel)

3. A vena caval filter

4. Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed

5. Has a life expectancy less than 5 years

6. Is unable to attend follow-up visits because of geographic inaccessibility

7. Is participating in a competing clinical investigation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anticoagulant Therapy	Continue on anticoagulant therapy (positive d-dimer)	Continue on anticoagulant therapy
No Anticoagulant Therapy	Discontinue anticoagulant therapy (Negative d-dimer)	No Anticoagulant Therapy

Primary Outcome Measures

Name	Time	Method
Suspected Recurrent DVT	up to 7 years
Suspected (recurrent) pulmonary embolism	up to 7 years
Bleeding	up to 7 years
Death	up to 7 years

Trial Locations

Locations (13)

Limerick, Mid Western Regional Hospital; 🇮🇪 Limerick, Ireland

Beth Israel Deaconess Medical Centre; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

UNC Thrombophilia Program; 🇺🇸 Chapel Hill, North Carolina, United States

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Intermountain Medical Centre; 🇺🇸 Murray, Utah, United States

Henderson Hospital; 🇨🇦 Hamilton, Ontario, Canada

St. Joseph's Health Care Centre; 🇨🇦 Hamilton, Ontario, Canada

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom