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Sponsors and Collaborators: |
Eli Lilly and Company Daiichi Sankyo Co., Ltd. DCRI |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00699998 |
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).
Condition | Intervention | Phase |
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Acute Coronary Syndrome |
Drug: Clopidogrel Drug: Prasugrel Drug: Commercially-available Aspirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed |
Estimated Enrollment: | 10300 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Prasugrel and Low-dose Commercially-available Aspirin
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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
Drug: Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study
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2: Active Comparator
Clopidogrel and Low-Dose Commercially-available Aspirin
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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: Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
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 |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 11058, H7T-MC-TABY(b) |
Study First Received: | June 16, 2008 |
Last Updated: | August 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00699998 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ACS |
Heart Diseases Aspirin Clopidogrel Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases |
Angina Pectoris Platelet Aggregation Inhibitors Ischemia Infarction Angina, Unstable Myocardial Infarction |
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 |