Status:
COMPLETED
Does Low Dose Oral Vitamin K Improve International Normalized Ratio (INR) Stability?
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborating Sponsors:
McMaster University
University of Western Ontario, Canada
Conditions:
Coagulation
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Warfarin is highly effective for the prevention of both first and recurrent thrombotic events, however even minor excursions outside the reference INR range of 2.0 to 3.0 are associated with bleeding ...
Detailed Description
What is/are the principal research objective(s) and question(s) to be addressed? Research Objectives: Our broad objective is to improve the quality of anticoagulant care for patients receiving warfari...
Eligibility Criteria
Inclusion
- Warfarin therapy administered to a target INR of 2.0 to 3.0
Exclusion
- Out of range INR on day of screening - enrolment will only occur if the patient's INR on the day of screening is between 1.8 and 3.4 (inclusive) - if the INR is outside this range the patient will be re-screened when the INR is within this range.
- Recent warfarin initiation - all patients must have received warfarin for a minimum of 3 months
- Planned termination or extended temporary interruption of warfarin within 6 months or anticipated survival of less than 6 months
- Known severe liver disease, known excess alcohol consumption , known malabsorption syndrome or inability to take oral medications
- Use of medications known to interfere with warfarin and whose dose is likely to change over the course of the study (e.g. barbiturates, rifampin etc.)
- Known allergy to vitamin K
- Inability or unwillingness to follow study procedures or provide consent
- Prior participation in this study, or participating in a competing study which may impact INR control
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00990158
Start Date
July 1 2010
End Date
April 1 2014
Last Update
May 21 2015
Active Locations (4)
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1
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L 2X2
2
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
3
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
4
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4