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

Study Overview
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Brief Summary
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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.

Official Title
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PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Prasugrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prasugrel low dose<br>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. | Drug: Prasugrel<br>* 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.<br>|
| Experimental: Clopidogrel standard dose<br>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. | Drug: Clopidogrel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Bleeding (major, minor, or minimal according to the TIMI study criteria) | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiplatelet effect, prasugrel, clopidogrel, acute coronary syndrome