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

Phase 3

• Conditions: Coronary Artery Disease
• Interventions: Drug: Prasugrel; Drug: Clopidogrel

• Registration Number: NCT01778842
• Lead Sponsor: Gennaro Sardella

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-24
• Last Update Submitted: 2013-01-24
• Study First Posted: 2013-01-29
• Last Update Posted: 2013-01-29
• Study Start: 2013-03
• Primary Completion: 2013-06
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel low dose	Prasugrel	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.
Clopidogrel standard dose	Clopidogrel	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.

Primary Outcome Measures

Name	Time	Method
superiority of prasugrel low dose	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Bleeding	12 months	Bleeding (major, minor, or minimal according to the TIMI study criteria)
major adverse cardiac events	12 months	major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.

Trial Locations

Locations (1)

Dept.of Cardiovascular Sciences,Policlinico Umberto I; 🇮🇹 Rome, Italy