Coagulation Delay Clinical Trial
Official title:
Use of Phytonadione to Reduce INR Variability in Patients on Long-term Warfarin Therapy
Background: Warfarin is used as an anti-coagulant in patients at risk of developing
thrombosis. It has a narrow therapeutic index necessitating close monitoring of
International Normalized Ratio (INR). According to a meta-analysis, patients were in
therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis.
Various retrospective and prospective studies have looked at supplementation with
phytonadione in these patients to reduce the variability of INR showing an improvement in
variability. Most of these studies have only been done in a small number of patients already
on warfarin therapy. This study will focus on patients newly starting warfarin therapy.
Methods: This study is a prospective, randomized, controlled trial performed at James A.
Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will
receive either phytonadione with warfarin or warfarin alone. Based on a power calculation
for 80%, a total of 370 patients will be enrolled (185 participants in each arm).
Participants will be randomized to either intervention or control. Intervention group
participants will be prescribed their usual starting dose of warfarin along with 200 mcg
phytonadione by mouth daily. Control group participants will be prescribed their usual
starting dose of warfarin. Both groups will follow the usual standard of care. They will
come in for a follow-up INR and warfarin dose titration at least once per week until
therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will
participate in anticoagulation clinic activities that constitute the current standard of
care. Intervention will last for a total of 6 months for each participant once enrolled.
Hypothesis:Participants in the intervention group being supplemented with 200mcg of
phytonadione will spend more total time with a therapeutic INR than participants in the
control group.
See above. ;
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