Status:
COMPLETED
Prothrombin Times Outside the Therapeutic Range in Otherwise Stable Patients
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Atrial Fibrillation
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Warfarin is very effective for the prevention of blood clots (thrombosis). A test of coagulation, the prothrombin time (PT) is used to monitor the effect. The PT response to warfarin can fluctuate as ...
Detailed Description
Setting: Thrombosis Service at HHS - General Hospital. This center monitors the warfarin treatment for 1300 patients in the region. These patient regularly go to a laboratory where they live. Test re...
Eligibility Criteria
Inclusion
- Patients on long-term warfarin (for prophylaxis of arterial embolism in patients with atrial fibrillation or mechanical heart valve replacement, or secondary prophylaxis after VTE) with a target INR of 2.0-3.0 or 2.5-3.5,
- Anticoagulant therapy managed by the clinic (HHS - General Hospital) for at least 3 months prior to enrolment, and
- Maintenance dose of warfarin unchanged for the previous 3 months or longer.
- The INR result is outside the therapeutic range as follows:
- For those with target 2.0-3.0: Either an INR of 1.5-1.9 or an INR of 3.1-4.4. For those with target 2.5-3.5: Either an INR of 1.5-2.4 or an INR of 3.6-4.4.
Exclusion
- Age \<18 years,
- Long-term (\>1 week) change in any other medication
- Long-term (\>1 week) change in diet, especially regarding green vegetables.
- Attending physician believes the patient is not suitable for the study (e.g. psychiatric disorder, history of non-compliance),
- Failure to obtain telephone consent.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00814177
Start Date
July 1 2006
End Date
April 1 2009
Last Update
August 1 2012
Active Locations (1)
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1
Thrombosis Service, HHS-General Hospital
Hamilton, Ontario, Canada, L8L 2X2