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

NCT ID: NCT01778842

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-07-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prasugrel

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: 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.

Interventions

Clopidogrel

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.

Intervention Type: DRUG

Prasugrel

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gennaro Sardella

OTHER

Sponsor Role: lead

Responsible Party

Gennaro Sardella

Associate Professor in Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, Rome, Italy

Countries

Italy

Central Contacts

Gennaro Sardella, MD

Role: CONTACT

rino.sardella@uniroma1.it

+390649979035

Facility Contacts

Rocco Stio, MD

Role: primary

rocco.stio@libero.it

+300649979046

Other Identifiers

RESET ELDERLY

Identifier Type: -

Identifier Source: org_study_id