Pharmacogenetics of Warfarin in Puerto Ricans.
|ClinicalTrials.gov Identifier: NCT01318057|
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : January 21, 2015
|Condition or disease|
|Atrial Fibrillation Deep Vein Thrombosis Cardiac Valvular Insufficiency Antiphospholipid Syndrome Coagulopathy|
|Study Type :||Observational|
|Actual Enrollment :||350 participants|
|Official Title:||Pharmacogenetics of Warfarin in Puerto Rican Patients Using a Physiogenomics Approach.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
U.S. FDA Resources
Wild-Type are those individuals who were non-carriers of any functional (loss-of-function)variant in CYP2C9 and/or VKORC1 genes
Those patients who were identified as having any functional CYP2C9 and/or VKORC1 polymorphism
- time to achieve stable warfarin dose [ Time Frame: 6 months ]time to get a stable warfarin dose is defined by the time span (days) from the initial dose until achieving three consecutive INR measurements within therapeutic range (2-3 or 2.5-3.5, according to indication.
- time to first bleeding [ Time Frame: 6 months ]time to first bleeding is defined as the time span (days) from the initiation of therapy until the first report of serious or life-threatening bleeding episode.
- time to first INR>4 [ Time Frame: 6 months ]time to first INR above 4 is an indicator of overanticoagulation that is defined as the time span (days) from the initiation of therapy until the first measurement of INR above 4.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318057
|Veteran Affair Caribbean Healthcare System|
|San Juan, Puerto Rico, 00921|
|Principal Investigator:||Giselle T Rivera-Miranda, PharmD||VACHS at San Juan|
|Principal Investigator:||Jorge Duconge, PhD||University of Puerto Rico|