Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377143
Status:
WITHDRAWN
Last Update Posted:
2012-02-16
First Post:
2006-09-13
Brief Title:
PRospective Evaluation Comparing Initiation of Warfarin StrategiEs PRECISE Pharmacogenetic-guided Versus Usual Care
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
PRospective Evaluation Comparing Initiation of Warfarin StrategiEs PRECISE Pharmacogenetic-guided Versus Usual Care
Status:
WITHDRAWN
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
similar large study planned by NHLBI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 persons 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 persons specific health and genetic information to calculate a patients warfarin dose at the beginning of warfarin treatment The hope is that through this research we may someday be able to use an individuals 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
Detailed Description:
Warfarin is the mainstay of therapy in preventing venous thromboembolism VTE pulmonary embolism PE and subsequent morbidity and mortality Despite its proven efficacy in reducing the advent of clot formation patient-specific warfarin dosing is difficult to predict with the initial dose regimen often resulting in supra- and subtherapeutic anticoagulation and subsequently increasing patients risk of bleeding or embolism It has been shown that interpatient warfarin dosing variability is due in part to genetic variations found in the cytochrome P450 2C9 metabolism pathway CYP2C9 as well as proteins involved in the coagulation cascade most importantly vitamin K epoxide reductase complex subunit 1 VKORC1 A recent retrospective study has shown that these two genes in addition to several clinicaldemographic factors account for greater than 58 of the variation in patient-specific warfarin doses However there have been no studies documenting prospective use of this information in selecting an initial warfarin dose Hypothesis Stable therapeutic management of warfarin therapy can be more precisely achieved when patients are prospectively dosed based on a pharmacogenetic-guided dosing equation compared to usual care Aim a To determine if pharmacogenetic-guided dosing of warfarin is superior to usual care when defined as the accuracy of the initial versus the stable warfarin dose This will be assessed as the mean absolute difference in initial versus stable dose Aim b To determine if a stable warfarin dose is more quickly achieved using the pharmacogenetic-guided dosing equation compared to usual care This will be assessed as time to stable dose Aim c To determine if pharmacogenetic-guided dosing is superior to usual care in terms of overdosing and underdosing patients This will be assessed as the fraction of the population overdosed and the fraction of population underdosed by the two methods We propose to evaluate a pharmacogenetic-guided dosing approach compared to usual care in the initiation of warfarin management The selected pharmacogenetic-guided equation is a validated equation that includes both genetic and clinical factors and is relatively easy to incorporate into current clinical practice Patients newly initiating warfarin therapy in a hospital setting will be randomized to receive either pharmacogenetic-guided or usual care with follow-up anticoagulation management services provided by the University of Florida Health System Anticoagulation Clinic Prospectively determining patients stable dose has important clinical implications in todays management of warfarin therapy Being able to predetermine a patients stable dose upon initiation of therapy has the potential to decrease the time spent in supra- and subtherapeutic anticoagulation and reduce the number of clinic visits required to achieve a stable dose Therefore we propose this study to test if using genotype data in determining the initial warfarin dose is more effective than usual care in predicting stable dose If we can document the value of such an approach this will provide the level of evidence needed to translate pharmacogenetic-guided dosing of warfarin into clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None