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A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects (TRILOGY ACS)

Tracking Information

Start Date ^ICMJE	June 2008
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2008)	Reduction in risk of the composite endpoint of first occurrence of CV death, MI, or stroke. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00699998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2008)	Risk of the composite endpoint of first occurence of CV death and MI. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ] Risk of the composite endpoint of first occurrence CV death, MI, stroke, or re-hospitalization for recurrent UA. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ] Risk of the composite endpoint of first occurrence of all-cause death, MI, or stroke. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ] Platelet aggregation measures. [ Time Frame: Baseline and at various timepoints during study treatment. ] [ Designated as safety issue: No ] Biomarker measurements of inflammation/hemodynamic stress. [ Time Frame: Baseline and at various timepoints during study treatment. ] [ Designated as safety issue: No ] Genotyping related to drug metabolism. [ Time Frame: Baseline ] [ Designated as safety issue: No ] Economic and Quality of Life Outcomes. [ Time Frame: Baseline, follow-up, and discontinuation from study. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information

Brief Title ^ICMJE	A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
Official Title ^ICMJE	A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
Brief Summary	This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed UA/NSTEMI ACS population (that is, patients who are not managed with acute coronary revascularization).
Detailed Description	Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TRILOGY ACS study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Acute Coronary Syndrome
Intervention ^ICMJE	Drug: Clopidogrel 300mg, oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75mg, oral, once daily as maintenance dose through end of study Drug: Prasugrel 30mg, oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5mg or 10mg (based upon weight and age), oral, once daily as maintenance dose through end of study Other Names: LY640315 Effient Efient CS-747 Drug: Commercially-available Aspirin Low-dose aspirin, oral, as prescribed by physician through end of study
Study Arms / Comparison Groups	1: Experimental Prasugrel and Low-dose Commercially-available Aspirin Interventions: Drug: Prasugrel Drug: Commercially-available Aspirin 2: Active Comparator Clopidogrel and Low-Dose Commercially-available Aspirin Interventions: Drug: Clopidogrel Drug: Commercially-available Aspirin

Recruitment Information

Estimated Enrollment ^ICMJE

10300

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion Criteria:

Have had a UA/NSTEMI index event within 10 days prior to randomization
Had a medical management strategy decision made with reasonable certainty that neither PCI nor CABG is planned for treatment of the index event
Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key Exclusion Criteria:

Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
Insignificant CAD on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
Previous or planned PCI or CABG as treatment for the index event
PCI/CABG within previous 30 days
STEMI as the index event
Cardiogenic shock, Refractory ventricular arrhythmias, NYHA Class IV CHF within the previous 24 hours
History of ischemic or hemorrhagic stroke, TIA, Intracranial neoplasm, arteriovenous malformation, or aneurysm
History of spontaneous GI or non-GI bleeding requiring hospitalization for treatment, unless definitive Rx has occurred and there is low likelihood of recurrence
Hemodialysis or peritoneal dialysis

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Location Countries ^ICMJE

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00699998

Responsible Party

Chief Medical Officer, Eli Lilly

Study ID Numbers ^ICMJE

11058, H7T-MC-TABY(b)

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Daiichi Sankyo Co., Ltd.
Duke University

Investigators ^ICMJE

Study Director:

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

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Source: http://clinicaltrials.gov/