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

NCT01778842 | Unknown Phase 3 DMC

• 1 other identifier: RESET ELDERLY
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

antiplatelet effect; prasugrel; clopidogrel; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bleeding

  12 months

• major adverse cardiac events

  12 months

Study Arms (2)

Prasugrel low dose

EXPERIMENTAL

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

Clopidogrel standard dose

EXPERIMENTAL

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

Interventions

Clopidogrel 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.

Clopidogrel standard dose

Prasugrel 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.

Prasugrel low dose

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Acute coronary syndrome
• PCI with stent implantation
• clopidogrel responsiveness
• \> 75 years of age.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gennaro Sardella: lead

Study Sites (1)

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, Rome, 000161, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Interventions

Clopidogrel; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines

Central Study Contacts

Gennaro Sardella, MD

CONTACT

+390649979035; rino.sardella@uniroma1.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Cardiology

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

IT (1)