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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01778842

Acronym

RESET ELDERLY

Enrollment

Registered

2013-01-29

Start date

2013-03-31

Completion date

2013-07-31

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

antiplatelet effect, prasugrel, clopidogrel, acute coronary syndrome

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.

Interventions

DRUGClopidogrel

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.

DRUGPrasugrel

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactGennaro Sardella, MD

rino.sardella@uniroma1.it+390649979035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026