At a glance
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A Multicentre Study of Low Dose Oral Vitamin K for INR Control in Patients Receiving Warfarin
In Brief
A Phase 3 clinical trial evaluating Phytonadione (Vitamin K1) and Placebo for Coagulation and 2 related conditions. Completed, enrolled 235 participants across 4 sites.
Detailed 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 or thrombotic complications. The importance of maintaining the INR within the desired interval has led to the concept of "time in therapeutic range (TTR)" - the total proportion of time that the INR is between 2.0 and 3.0. The investigators propose a multicentre, double blind, randomized trial which will determine if 0.150 mg of oral vitamin K increases time in the therapeutic range for patients receiving warfarin.
Study Details
Timeline
Interventions
A daily dose of 150 micrograms of vitamin K medication given orally for a total of 7 months
A daily dose of matching placebo medication given orally for a total of 7 months