A comparison of reduced-dose prasugrel and clopidogrel in elderly patients with acute coronary syndrome undergoing early revascularization

A comparison of reduced-dose prasugrel and clopidogrel in elderly patients with acute coronary syndrome undergoing early PCI - The elderly-ACS 2 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002882-37-IT

Enrollment

2000

Registered

2012-09-03

Start date

2012-08-28

Completion date

Unknown

Last updated

2022-03-14

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

Conditions

Acute coronary syndrome MedDRA version: 15.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: EFIENT*84CPR RIV 5MG Pharmaceutical Form: Coated tablet INN or Proposed INN: PRASUGREL CAS Number: 150322-43-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 48 hours, and candidates to an early PCI. Patients must be able to provide written informed consent before randomization. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000

Exclusion criteria

Exclusion criteria: • History of stroke or TIA • Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization. • Hemoglobin level on admission 1.5 at the time of screening. • Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol. • Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization • Inhability to give at least verbal informed consent to the study. . Contraindications to the use of clopidogrel or prasugrel as per package leaflet

Design outcomes

Primary

Measure	Time frame
Main Objective: comparing reduced-dose prasugrel and standard dose clopidogrel with regard to the primary endpoint of the study;Secondary Objective: To assess the prognostic impact of selected pre-randomization variables;Primary end point(s): The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year.;Timepoint(s) of evaluation of this end point: up to 12 months	—

Measure

Time frame

Main Objective: comparing reduced-dose prasugrel and standard dose clopidogrel with regard to the primary endpoint of the study;Secondary Objective: To assess the prognostic impact of selected pre-randomization variables;Primary end point(s): The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year.;Timepoint(s) of evaluation of this end point: up to 12 months

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Secondary

Measure	Time frame
Secondary end point(s): • The burden (global occurrence) of recurrent cardiovascular events • Cardiovascular mortality at one year • All-cause mortality and myocardial (re)infarction at 1 year • Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding within 12 months (for bleedings occurring during index or subsequent hospitalizations) • BARC type IV bleeding within one year • Any stroke within 12 months • Total number of days spent in hospital within 12 months after index admission.;Timepoint(s) of evaluation of this end point: up to 12 months	—

Measure

Time frame

Secondary end point(s): • The burden (global occurrence) of recurrent cardiovascular events • Cardiovascular mortality at one year • All-cause mortality and myocardial (re)infarction at 1 year • Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding within 12 months (for bleedings occurring during index or subsequent hospitalizations) • BARC type IV bleeding within one year • Any stroke within 12 months • Total number of days spent in hospital within 12 months after index admission.;Timepoint(s) of evaluation of this end point: up to 12 months

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Countries

Italy

Contacts

Public ContactRicerca Clinica

Mediolanum Cardio Research

info@mcr-med.com0234535088

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026