Genotyped Guided Dosing of Warfarin Clinical Treatment Studies

The Genotype Guided Dosing of Warfarin Clinical Trial, sponsored by the National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), is soliciting applications from suitable clinical research centers. The University of Pennsylvania serves as the Clinical Trial Coordinating Center (CTCC) for this study. Clinical sites will participate as a subcontract to the CTCC. A Steering Committee will provide leadership to the study. Dr. Robert Califf will serve as the Steering Committee Chair. Clinical site Principal Investigators will participate on the Steering Committee on a rotating basis.

The objective of this study is to advance the field of clinical treatment and dose management of warfarin sodium by determining the optimal dosing of warfarin.  Warfarin is highly efficacious at preventing thromboembolism (TE), a condition associated with substantial morbidity and mortality.  However, warfarin must be dosed properly to avoid life-threatening complications (from overdosing) and lost efficacy (from underdosing).  Current practice relies primarily on empirical dosing, leading to improper levels of anticoagulation (AC), particularly during the dose titration period.  Because of improper dosing and warfarin’s tremendous use, warfarin contributes to substantial complications in the population.  Improper dosing can lead to increased medical costs, reduced quality of life, patient dissatisfaction, and discontinuation of highly-efficacious therapy. Read Full Article