Genotype Information and Functional Testing Study (GIFT)
This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||GIFT: Genotype Information and Functional Testing Study|
- residual platelet reactivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
GRAVITAS Study Arm A
"Tailored" clopidogrel regimen - total first day dose 600-mg, then 150-mg every day for 6 months
GRAVITAS Study Arm B
"Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets) and then clopidogrel 75-mg and 1 placebo tablet every day for 6 months.
GRAVITAS Study Arm C
Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets) and then the standard clopidogrel regimen of 75-mg and 1 placebo tablet every day for 6 months.
|United States, California|
|Scripps Genomic Medicine|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Matthew J Price, MD||Scripps Clinic, La Jolla, CA|