Coronary Artery Disease
Conditions
Keywords
thienopyridine, platelets, CYP2C19, clopidogrel, platelet function tests, platelet, genes, cytochrome P450, single nucleotide polymorphisms, Platelet Aggregation Inhibitors
Brief summary
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.
Detailed description
AS DESCRIBED BY THE PI: 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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Sanofi
Accumetrics, Inc.
Scripps Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination
Exclusion criteria
* See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| residual platelet reactivity | 6 months | Outcome 1 is residual platelet reactivity the measurement |
Countries
United States
Outcome results
None listed