University of Pennsylvania School of Medicine

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Genotyped Guided Dosing of Warfarin Clinical Trial

Funding Opportunity - Central Laboratory & Clinical Site RFP

Image of Pharmacist Measuring Pills (Stock Photo)


Number 002
Release Date July 16, 2008
Due Date September 3 , 2008


Note: Submission Deadline Extended to September 3, 2008

Central Laboratory RFP (html)   (pdf 103kb)   (MS Word 608kb)

Trial Summary

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. 

Although clinical research has identified clinical and genetic factors that can alter warfarin dose requirements, limited prospective, clinical research has examined the utility of using clinical and genetic information to improve outcomes among a large, diverse group of patients using warfarin.  In August 2007, the U.S. Food and Drug Administration (FDA) announced the approval of updated labeling for warfarin, to explain that patients’ genetic makeup may influence how they respond to the drug. In addition, genetic tests are now widely available that provide rapid results to potentially inform clinical decisions about warfarin dosing.

This is a randomized, multicenter, double-blind trial comparing three approaches to guiding warfarin therapy initiation.  Participants will be recruited from approximately 12 North American clinical sites prior to initiating warfarin. Based on the need for approximately 1,965 patients in the trial, each site will recruit approximately 164 patients into the trial over an 18 month period, or approximately 9 patients per month. Patients must be identified and enrolled prior to the first dose of warfarin, and they should be patients who are warfarin naïve or for whom any previous therapeutic warfarin dose is unknown.

Clinical Site RFP (html)   (pdf 85kb)     (MS Word 623kb)    (Receipt Date Closed)

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