Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome (RESET ELDERLY)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy.|
- superiority of prasugrel low dose [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]The primary aim will be to investigate the antiplatelet effect of half dose of prasugrel (5 mg) versus standard dose of clopidogrel in patients with acute coronary syndrome and coronary diseases, treated with percutaneous coronary intervention and stent implantation.
- Bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Bleeding (major, minor, or minimal according to the TIMI study criteria)
- major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Prasugrel low dose
Patient will be randomized to this intervention will receive prasugrel 5 mg and after 15 days and 30 days we will control the responsivness of the study drug.
Patient will be randomized to this intervention will receive the low dose of prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
Experimental: Clopidogrel standard dose
Patient will be randomized to this intervention will receive clopidogrel 75 mg and after 15 days and 30 days we will control the responsivness of the study drug.
Patient will be randomized to this intervention will receive the standard dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778842
|Contact: Gennaro Sardella, MDemail@example.com|
|Dept.of Cardiovascular Sciences,Policlinico Umberto I||Not yet recruiting|
|Rome, Italy, 000161|
|Contact: Rocco Stio, MD +300649979046 firstname.lastname@example.org|