Overview

PRospective Evaluation Comparing Initiation of Warfarin StrategiEs (PRECISE): Pharmacogenetic-guided Versus Usual Care

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients to help prevent blood clots from forming or to help prevent the growth of an existing blood clot. The purpose of this study is to collect information on a possible method used to determine the best warfarin dose for people before they start warfarin. This study will focus on finding out if a person's stable dose can be better predicted by using a new approach (called "pharmacogenetic-guided dosing") compared to the current warfarin dosing method. The pharmacogenetic-guided dosing method (the new warfarin dosing method) will use a person's specific health and genetic information to calculate a patient's warfarin dose at the beginning of warfarin treatment. The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their specific warfarin dose at the beginning of treatment, leading to precise warfarin dosing and less need for the current trial and error process.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Treatments:
Warfarin
Criteria
Inclusion Criteria:

- Newly initiating warfarin

Exclusion Criteria:

- Previous use of warfarin

- Cancer

- Hepatic Disease

- History of alcoholism

- Diarrheal illness

- Febrile Illness

- Blood dyscrasias

- Pregnancy

- Medical plan to hold warfarin administration before stable dose is achieved (ie. for
surgical intervention)

- Dementia

- Active bleed

- Aneurysm