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

Sponsors: Eli Lilly and Company


Purpose
 

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).

ConditionInterventionPhase
Acute Coronary SyndromeDrug: 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

 


 

 

 



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.

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 Eligibility


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

Criteria

Inclusion Criteria:

  • Have had a UA/NSTEMI index event within 7 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 events
  • Had at least 1 of 3 specified high-risk features at the time of the UA/NSTEMI event
  • Have at least 1 native coronary artery stenosis greater than 50% (if diagnostic coronary angiography performed during the index event hospitalization).
Exclusion Criteria:
 
  • Decision for medical management greater than 24 hours after onset of index event without commercial clopidogrel treatment within 24 hours following onset of the index event.
  • Previous or planned PCI or CABG as treatment for the index event
  • PCI or CABG within the 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 internal bleeding requiring in-hospital treatment
  • Hemodialysis or peritoneal dialysis
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Contacts
 

Physicians:
Ameer Kabour, MD
Tarif Kanaan, MD
Raza Hashmi, MD
Mohammad Alkhateeb, MD

Coordinators:
Julie Neidhardt, RN, BSN
Michelle Hickam, RN, BSN
Brenda Hoagland, RN, CCRC

Please contact us at 419-251-4919 for further information about this study.

 

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