Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study - Full Text View

Sponsor:	Medco Health Solutions, Inc.
Information provided by:	Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier:	NCT00995514

Purpose

This study is designed to compare the effectiveness of clopidogrel in CYP2C19 extensive metabolizers (EM) with prasugrel in adults recently hospitalized for acute coronary syndrome (ACS) with primary, delayed, or planned percutaneous coronary intervention (PCI).

Condition
Acute Coronary Syndrome

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study

Resource links provided by NLM:

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Further study details as provided by Medco Health Solutions, Inc.:

Primary Outcome Measures:

To assess the non-inferiority of clopidogrel therapy in those subjects who are CYP2C19 extensive metabolizers compared to prasugrel therapy on the composite primary end point of cardiovascular death, nonfatal MI, or nonfatal stroke. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the incidence of individual components of the primary end point. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The incidence of hospitalization for other cardiovascular events not included in the primary composite endpoint to include coronary revascularization, unstable angina, and heart failure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Total health care resource utilization and cost-effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Health-related quality of life and activity/work productivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of hospitalization for site- and cause-specific bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Incidence of new or recurrent cancer [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Saliva

Estimated Enrollment:	14600
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Clopidogrel Patients receiving clopidogrel 75 mg/day as prescribed by their physician, and are extensive metabolizers by CYP2C19 genotype
Prasugrel Patients receiving prasugrel 5 or 10 mg/day as prescribed by their physician

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with a recent verified ACS hospitalization (with or without primary or delayed PCI) prescribed clopidogrel or prasugrel for the first time or are ≥4 months from previous clopidogrel or prasugrel therapy.

Criteria

Inclusion Criteria:

Men and women between 18 years and 75 years of age
History of ACS hospitalization for unstable angina (UA), non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) with primary or delayed PCI.
ACS hospitalization within 30 days prior to index clopidogrel or prasugrel prescription claim.
Participant is willing and able to provide informed consent.

Exclusion Criteria:

Previous use of any thienopyridine within 4 months of initiating new clopidogrel or prasugrel therapy.
Previous history of PCI or CABG within four months prior to index event.
Participant refusal to participate in the study.
Physician refusal to participate in the study.
Anticipated discontinuation of clopidogrel or prasugrel within the 6 month study follow-up period
Any condition that would prevent the subject from completing the 6 month study follow-up period
Participants that have previously stated "do not contact"

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995514

Locations

United States, New Jersey
Medco Health Solutions, Inc
Franklin Lakes, New Jersey, United States, 07417

Sponsors and Collaborators

Medco Health Solutions, Inc.

Investigators

Principal Investigator:

Eric J Stanek, Pharm.D.

Medco Health Solutions, Inc.

More Information

Additional Information:

Plavix prescribing information This link exits the ClinicalTrials.gov site

Effient prescribing information This link exits the ClinicalTrials.gov site

Publications:

Collet JP, Hulot JS, Pena A, Villard E, Esteve JB, Silvain J, Payot L, Brugier D, Cayla G, Beygui F, Bensimon G, Funck-Brentano C, Montalescot G. Cytochrome P450 2C19 polymorphism in young patients treated with clopidogrel after myocardial infarction: a cohort study. Lancet. 2009 Jan 24;373(9660):309-17. Epub 2008 Dec 26.

Trenk D, Hochholzer W, Fromm MF, Chialda LE, Pahl A, Valina CM, Stratz C, Schmiebusch P, Bestehorn HP, Büttner HJ, Neumann FJ. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical outcome of elective percutaneous coronary intervention with drug-eluting or bare-metal stents. J Am Coll Cardiol. 2008 May 20;51(20):1925-34.

Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. Epub 2007 Nov 4.

Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias W, Braunwald E, Sabatine MS. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009 Jan 22;360(4):354-62. Epub 2008 Dec 22.

Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Méneveau N, Steg PG, Ferrières J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. Epub 2008 Dec 22.

Responsible Party:	Medco Health Solutions, Inc ( Eric J Stanek, Pharm.D. Senior Director, Research, Personalized Medicine )
Study ID Numbers:	GeCCO1
Study First Received:	October 14, 2009
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00995514 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medco Health Solutions, Inc.:

acute coronary syndrome
cardiovascular death
non-fatal MI
non-fatal stroke
genetic testing
CYP2C19

clopidogrel
prasugrel
antiplatelet therapy
genotyping
bleeding

Additional relevant MeSH terms:

Disease
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Pharmacologic Actions
Pathologic Processes

Syndrome
Clopidogrel
Therapeutic Uses
Acute Coronary Syndrome
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010