A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00097591

Purpose

The sponsors of this investigational drug are developing prasugrel as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel will be compared with clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Condition	Intervention	Phase
Coronary Arteriosclerosis Acute Coronary Syndrome	Drug: Prasugrel Drug: Clopidogrel	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Test the hypothesis that CS-747 plus aspirin is superior to clopidogrel plus aspirin in the treatment of subjects with acute coronary syndrome who are to undergo percutaneous coronary intervention (PCI),
as measured by a reduction in the composite endpoint of cardiovascular (CV) death,nonfatal myocardial infarction (MI), or nonfatal stroke at a median follow-up of at least 12 months

Secondary Outcome Measures:

Evaluate the incidence of major and minor bleeding events in subjects receiving CS-747 or Clopidogrel and overall safety and tolerability of CS-747

Estimated Enrollment:	13000
Study Start Date:	November 2004
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous intervention.
A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

A person who has had a stroke within the last 3 months.
A person who has active internal bleeding or has a history of a bleeding disorder.
Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician.
A person who has liver disease; for example, cirrhosis.
A person who has a condition such as alcoholism, mental illness, or is drug dependent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097591

Locations

United States, Indiana
For more information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Global Quintiles Study Line (1-866-615-4672) or speak with your physician
Indianapolis, Indiana, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Mahoney EM, Wang K, Arnold SV, Proskorovsky I, Wiviott S, Antman E, Braunwald E, Cohen DJ. Cost-effectiveness of prasugrel versus clopidogrel in patients with acute coronary syndromes and planned percutaneous coronary intervention: results from the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with Prasugrel-Thrombolysis in Myocardial Infarction TRITON-TIMI 38. Circulation. 2010 Jan 5;121(1):71-9. Epub 2009 Dec 21.

Pride YB, Wiviott SD, Buros JL, Zorkun C, Tariq MU, Antman EM, Braunwald E, Gibson CM; TIMI Study Group. Effect of prasugrel versus clopidogrel on outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention without stent implantation: a TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel (TRITON)-Thrombolysis in Myocardial Infarction (TIMI) 38 substudy. Am Heart J. 2009 Sep;158(3):e21-6.

Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31.

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.

Wiviott SD, Braunwald E, Angiolillo DJ, Meisel S, Dalby AJ, Verheugt FW, Goodman SG, Corbalan R, Purdy DA, Murphy SA, McCabe CH, Antman EM; TRITON-TIMI 38 Investigators. Greater clinical benefit of more intensive oral antiplatelet therapy with prasugrel in patients with diabetes mellitus in the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-Thrombolysis in Myocardial Infarction 38. Circulation. 2008 Oct 14;118(16):1626-36. Epub 2008 Aug 31.

Antman EM, Wiviott SD, Murphy SA, Voitk J, Hasin Y, Widimsky P, Chandna H, Macias W, McCabe CH, Braunwald E. Early and late benefits of prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction) analysis. J Am Coll Cardiol. 2008 May 27;51(21):2028-33.

Wiviott SD, Braunwald E, McCabe CH, Horvath I, Keltai M, Herrman JP, Van de Werf F, Downey WE, Scirica BM, Murphy SA, Antman EM; TRITON-TIMI 38 Investigators. Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial. Lancet. 2008 Apr 19;371(9621):1353-63. Epub 2008 Apr 2.

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.

Study ID Numbers:	8695, H7T-MC-TAAL
Study First Received:	November 24, 2004
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00097591 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Disease
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions
Coronary Disease

Pathologic Processes
Therapeutic Uses
Syndrome
Clopidogrel
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010