Pharmacogenetics of Warfarin in Puerto Ricans.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|