drugset / Trial / NCT01778842

Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome

NCT01778842

Phase 3 Unknown 68 enrolled Gennaro Sardella
RandomizedParallel-groupOpen-labelTreatment

Summary

The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.

Timeline

Start
2013-03
Primary completion
2013-06
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Clopidogrel Small molecule 75 mg
Subject Prasugrel Small molecule 5 mg