PATIENTS UNDERGOING CORONARY ANGIOPLASTY FOR ACUTE CORONARY SYNDROME TYPE STEMI / NSTEMI ESC MedDRA version: 9.1 Level: SOC Classification code 10047065 MedDRA version: 9.1 Level: SOC Classification code 10007541
Conditions
Interventions
Trade Name: PLAVIX
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Clopidogrel
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentration number: 75
Sponsors
OSPEDALE G.PASQUINUCCI-FONDAZIONE G.MONASTERIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AGE =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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; PLATELET1.5 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed