Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study

NCT00995514 | Terminated

• 1 other identifier: GeCCO1
• Study Type: observational
• Target: 4,471
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

acute coronary syndrome; cardiovascular death; non-fatal MI; non-fatal stroke; genetic testing; CYP2C19; clopidogrel; prasugrel; antiplatelet therapy; genotyping; bleeding

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of clopidogrel therapy in CYP2C19 extensive metabolizers with cardiovascular disease

  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

  6 months

Secondary Outcomes (6)

• Incidence between the two study groups of all individual components of the primary end point.

  6 and 12 months

• Total health care resource utilization and cost-effectiveness

  6 and 12 months

• Health-related quality of life and activity/work productivity

  6 and 12 months

• Incidence of hospitalization for site- and cause-specific bleeding

  6 and 12 months

• Incidence of new or recurrent cancer

  6 and 12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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"

Sponsors & Collaborators

• Medco Health Solutions, Inc.: lead

Study Sites (1)

Medco Health Solutions, Inc

Franklin Lakes, New Jersey, 07417, United States

Location

Related Publications (5)

• 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. doi: 10.1016/S0140-6736(08)61845-0. Epub 2008 Dec 26.

  PMID: 19108880 BACKGROUND

• Trenk D, Hochholzer W, Fromm MF, Chialda LE, Pahl A, Valina CM, Stratz C, Schmiebusch P, Bestehorn HP, Buttner 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. doi: 10.1016/j.jacc.2007.12.056.

  PMID: 18482659 BACKGROUND

• 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. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.

  PMID: 17982182 BACKGROUND

• 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. doi: 10.1056/NEJMoa0809171. Epub 2008 Dec 22.

  PMID: 19106084 BACKGROUND

• Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres 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. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

  PMID: 19106083 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome; Hemorrhage

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric J Stanek, Pharm.D.

  Medco Health Solutions, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Research

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 30, 2012

Record last verified: 2012-05

Locations

US (1)