Status:
COMPLETED
Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Atrial Fibrillation
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation) have a high risk of blood clot formation. Such clots can result in a stroke. The patients are treated with ...
Detailed Description
OBJECTIVE: The PRolongation of the INTerval between prothrombin time tests in stable patients (PRINT) is a single center, randomized, double-blind study to demonstrate that testing the prothrombin tim...
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 6 months prior to enrolment, and
- Maintenance dose of warfarin unchanged for the previous 6 months or longer.
Exclusion
- Age \<18 years,
- Life expectancy of less than 1 year,
- Attending physician believes the patient is not suitable for the study (e.g. psychiatric disorder, history of non-compliance),
- Geographic inaccessibility or
- Failure to obtain written consent.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00356759
Start Date
December 1 2006
End Date
February 1 2010
Last Update
August 22 2018
Active Locations (1)
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1
HHS - General Hospital, Thrombosis Service
Hamilton, Ontario, Canada, L8L 2X2