Genotype Information and Functional Testing Study

NCT00992420 | Completed

• 1 other identifier: P95082S
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

thienopyridine; platelets; CYP2C19; clopidogrel; platelet function tests; platelet; genes; cytochrome P450; single nucleotide polymorphisms; Platelet Aggregation Inhibitors

Outcome Measures

Primary Outcomes (1)

• residual platelet reactivity

  Outcome 1 is residual platelet reactivity the measurement

  6 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

• See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)

Sponsors & Collaborators

• Scripps Health: lead
• Bristol-Myers Squibb: collaborator
• Sanofi: collaborator
• Accumetrics, Inc.: collaborator

Study Sites (1)

Scripps Genomic Medicine

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Price MJ, Murray SS, Angiolillo DJ, Lillie E, Smith EN, Tisch RL, Schork NJ, Teirstein PS, Topol EJ; GIFT Investigators. Influence of genetic polymorphisms on the effect of high- and standard-dose clopidogrel after percutaneous coronary intervention: the GIFT (Genotype Information and Functional Testing) study. J Am Coll Cardiol. 2012 May 29;59(22):1928-37. doi: 10.1016/j.jacc.2011.11.068.

  PMID: 22624833 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Matthew J Price, MD

  Scripps Clinic, La Jolla, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 9, 2009
• Study Start: October 1, 2009
• Primary Completion: August 31, 2010
• Study Completion: August 31, 2010
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

US (1)