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

Sponsor:	Medco Health Solutions, Inc.
Information provided by (Responsible Party):	Eric Stanek, Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier:	NCT00995514

Purpose

The primary objective of this trial is to demonstrate the non-inferiority of clopidogrel compared to prasugrel over 6 months in cardiovascular disease patients when the clopidogrel cohort is limited to the estimated 70% of the population that are CYP2C19 extensive metabolizers. This protocol will examine the comparative effectiveness of these two strategies.

Condition
Cardiovascular Disease

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

Resource links provided by NLM:

Drug Information available for: Clopidogrel Bisulfate

U.S. FDA Resources

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

Primary Outcome Measures:

Non-inferiority of clopidogrel therapy in CYP2C19 extensive metabolizers with cardiovascular disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess the non-inferiority of clopidogrel therapy in patients with cardiovascular disease who are CYP2C19 extensive metabolizers (identified by genetic testing) compared to prasugrel therapy (non-genotyped) on the composite primary end point of cardiovascular death, hospitalization for acute coronary syndrome (nonfatal MI or unstable angina), nonfatal stroke or coronary revascularization

Secondary Outcome Measures:

Incidence between the two study groups of all individual components of the primary end point. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Number of hospitalizations and ER visits for other cardiovascular events not included in the primary composite endpoint.
- the primary (composite) endpoint and the individual components of the primary end point in subjects who are CYP2C19 intermediate metabolizers (IM) with clopidogrel EM and prasugrel populations
- the primary (composite) endpoint and the individual components of the primary end point in the population of CYP2C19 intermediate and extensive metabolizers with the prasugrel population.
Total health care resource utilization and cost-effectiveness [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Health-related quality of life and activity/work productivity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Incidence of hospitalization for site- and cause-specific bleeding [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
Incidence of new or recurrent cancer [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
To compare the incidence of the composite primary endpoint between the two study groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Saliva

Enrollment:	4450
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	August 2012 (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

Adults between the ages of 18 and 75 with newly initiated clopidogrel (Plavix) or prasugrel (Effient) therapy.

Criteria

Inclusion Criteria:

Men and women between 18 years and 75 years of age
Recent prescription for clopidogrel or prasugrel.
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.
Participant refusal to participate in the study.
Anticipated discontinuation of clopidogrel or prasugrel within 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:	Eric Stanek, Vice President, Research, Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier:	NCT00995514 History of Changes
Other Study ID Numbers:	GeCCO1
Study First Received:	October 14, 2009
Last Updated:	April 4, 2012
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:

Cardiovascular Diseases
Clopidogrel
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012