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news.Daiichi Sankyo Company and Eli Lilly and Company have announced that the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) study has failed to meet the primary endpoint.
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The Phase III trial was designed to compare prasugrel plus aspirin to clopidogrel plus aspirin in the patient population in acute coronary syndrome unstable angina (UA)/ non-ST elevation myocardial infarction (NSTEMI) patients to be managed medically without an artery-opening procedure.
The primary objective of the trial is to demonstrate prasugrel superiority over clopidogrel in the patients with UA or non-ST elevation myocardial infarction.
Eli Lilly and Company group vice president and Cardiovascular/acute care platform leader Anthony Ware said the large-scale clinical trials in understudied populations, such as TRILOGY ACS, are important regardless of the result because they generate a sizeable amount of information for the medical community.
"We look forward to presenting additional data from the platelet function sub-study, analyses of the elderly population data, as well as genomics information in future peer-reviewed forums," Ware added.
At 30 months, 13.9% of prasugrel patients versus 16.0% of clopidogrel patients experienced the combined primary endpoint of heart attack, stroke or cardiovascular (CV) death in patients under 75 years of age, the primary analysis population, which was not statistically significant (P=0.21).
ACS showed that rates of TIMI major bleeding events did not differ significantly between the prasugrel plus aspirin and clopidogrel plus aspirin treatment groups in patients less than 75 years of age or in the overall study population.