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A Cohort Study to Test That There is a Low Risk of Recurrent VTE in Patients With a First Episode of Unprovoked VTE Who Stop Anticoagulant Therapy After 3 Months of Treatment in Response to Negative D-dimer Testing


N/A
18 Years
75 Years
Open (Enrolling)
Both
Deep Vein Thrombosis, Pulmonary Embolism

Thank you

Trial Information

A Cohort Study to Test That There is a Low Risk of Recurrent VTE in Patients With a First Episode of Unprovoked VTE Who Stop Anticoagulant Therapy After 3 Months of Treatment in Response to Negative D-dimer Testing


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)

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Suspected Recurrent DVT

Outcome Time Frame:

up to 7 years

Safety Issue:

Yes

Principal Investigator

Clive Kearon, MB MRCP(I) FRCP(C) PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University

Authority:

Canada: Health Canada

Study ID:

CTMG-2007-DODS

NCT ID:

NCT00720915

Start Date:

September 2008

Completion Date:

May 2016

Related Keywords:

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • unprovoked deep vein thrombosis
  • unprovoked pulmonary embolism
  • anticoagulant therapy
  • Embolism
  • Pulmonary Embolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Lombardi Cancer CenterWashington, District of Columbia  20007
Henry Ford HospitalDetroit, Michigan  48202
Brigham and Women's HospitalBoston, Massachusetts  02115
Beth Israel Deaconess Medical CentreBoston, Massachusetts  02215
UNC Thrombophilia ProgramChapel Hill, North Carolina  27599-7035
Intermountain Medical CentreMurray, Utah  84152