Comparison between standard clopidogrel therapy and low dose of prasugrel in elderly patients.

Conditions: Patients over 75 years with acute coronary syndrome
MedDRA version: 16.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 16.1Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-000631-27-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Pazients over 75 years with acute coronary syndrome (unstable angina, NSTEMI and STEMI) undergoing percutanous coronary angioplasty and responder to clopidogrel therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
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 68

Exclusion Criteria

Pazients under 75 year and patients without acute coronary syndrome

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: We will assess the different variability in terms of therapeutic window maintenance between the two drugs. Bleeding (major, minor, or minimal according to the TIMI study criteria) and major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.;Primary end point(s): The primary end-point of the study is to demonstrate the superiority antiplatelet effect of half dose of prasugrel compared to standard dose of clopidogrel into therapeutic window, at the study periods. ;Timepoint(s) of evaluation of this end point: The timepoint of evaluation of this study is 1 month.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end-points included the rate MACCE (major adverse cerebro-cardiovascular events, i.e. the composite of death, myocardial infarction [defined according to the Academic Research Consortium statement],(17) target vessel revascularization or stroke), major bleedings (Bleeding Academic Consortium [BARC] 3-5),(18) minor bleeding (BARC 2), and NACE (net adverse clinical events, i.e. the composite of MACCE and major bleedings) up to 12 months;Timepoint(s) of evaluation of this end point: telephone-based interviews and office-based direct visits will be performed at 7-14-21 and 28 days and 12 months, respectively, for end-point adjudication.