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

Phase 1

• Conditions: Acute coronary syndrome; MedDRA version: 15.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002882-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-03
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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

•History of stroke or TIA
•Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
•Hemoglobin level on admission <10 g/dl, unless this is considered to be secondary to renal dysfunction or known mielodysplasia.
•Secondary causes of acute myocardial ischemia.
•Known current platelet count < 90,000 cells/?L.
•Ongoing oral anticoagulant treatment or an INR known to be >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •The burden (global occurrence) of recurrent cardiovascular events <br>•Cardiovascular mortality at one year <br>•All-cause mortality and myocardial (re)infarction at 1 year<br>•Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding within 12 months (for bleedings occurring during index or subsequent hospitalizations)<br>•BARC type IV bleeding within one year<br>•Any stroke within 12 months<br>•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