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

Gennaro Sardella68 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute coronary syndrome * PCI with stent implantation * clopidogrel responsiveness * \> 75 years of age. Exclusion Criteria: * history of bleeding diathesis * chronic oral anticoagulation treatment * contraindications to antiplatelet therapy * PCI or coronary artery bypass grafting (CABG) \< 3 months * hemodynamic instability * platelet count \< 100,000/μl * hematocrit \< 30% * creatinine clearance \< 25 ml/min * Patients with a history of stroke * other contraindication for prasugrel administration * patients weighing \< 60 kg * high on treatment platelet reactivity

Outcomes

Primary Outcomes

superiority of prasugrel low dose

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.

Time frame: 30 days

Secondary Outcomes

Bleeding

Bleeding (major, minor, or minimal according to the TIMI study criteria)

Time frame: 12 months

major adverse cardiac events

major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.