STANDARD VERSUS TAILORED ANTI-PLATELET THERAPY IN ACS PATIENTS UNDERGOING PERCUTANEOUS CORONARY ANGIOPLASTY - STAT STUDY

• Conditions: PATIENTS UNDERGOING CORONARY ANGIOPLASTY FOR ACUTE CORONARY SYNDROME TYPE STEMI / NSTEMI ESC; MedDRA version: 9.1Level: SOCClassification code 10047065; MedDRA version: 9.1Level: SOCClassification code 10007541

• Registration Number: EUCTR2009-010399-10-IT
• Lead Sponsor: OSPEDALE G.PASQUINUCCI-FONDAZIONE G.MONASTERIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

AGE < 80 YEARS; ACUTE CORONARY SYNDROME STEMI TYPE WITH INDICATION TO PRIMARY TO URGENT CORONAROGRAPHY GUIDELINES ESC 2007; SIGNATURE OF INFORMED CONSENT FORM.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

ANGIOPLASTY RESCUE; ACUTE HEART FAILURE; A STATEMENT TO REVASCULARIZATION CORONARY SURGICAL; CREATININE > 2.5.MG/L; ACTIVE BLEEDING OR SIGNIFICANT RISK OF BLEEDING; PLATELET<100.000/L; ANTICOAGULANT THERAPY IMPLEMENTED INR>1.5 GENITOURINARY OR SIGNIFICANT GASTROINTESTINAL BLEEDING 6 WEEKS PRIOR RANDOMIZATION; PARTICIPATION IN OTHER DEVICE OR DRUG STUDIES IN 30 DAYS PRIOR TO RANDOMIZATION; CURRENT MEDICAL CONDITION THAT PRECLUDE THE FOLLOW-UP PHASE OR THAT LIMITS PARTECIPATION IN THE PROTOCOL OF STUDY; INCAPACITY TO FURNISH AN INFORMED CONSENT AT LEAST VERBALY TO THE STUDY;

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: COMPARING THE STANDARD ANTIPLATELET THERAPY WITH A PERSONAL THERAPY FOR SINGLE PATIENT, BASED ON THE PROFILE OF ISCHEMIC HAEMORRHAGIC RISKS;Secondary Objective: EVALUATION OF THE SAFETY PROFILE OF THIS PERSONAL APPROACH (SAFETY);Primary end point(s): ENDPOINT COMPOSITE OF CARDIOVASCULAR MORTALITY, THROMBOSIS INTRASTENT / RECURRENCE OF MYOCARDIAL INFARCTION,DISABLING STROKE AND RE- HOSPITALIZED FOR BLEEDING, CLINICALLY SIGNIFICANT WITHIN 12 MONTHS FROM HOSPITAL DISCHARGE.