SWITCH STUDY

INTERVENTION: Trade Name: EFIENT*28CPR RIV 10MG Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: PRASUGREL HYDROCHLORIDE CAS Number: 389574‐19‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ CONDITION: NSTE‐ACS undergoing coronary angioplasty, already treated with clopidogrel in combination with aspirin at the time of the procedure ; MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: The aim of the study SWITCH is therefore to assess whether in patients with ACS without ST elevation, already treated with clopidogrel and undergoing stent implantation, a switch to prasugrel therapy might provide more protection from ischemic complications / thrombotic cardiac compared to standard therapy with clopidogrel. Primary end point(s): Incidence of major adverse cardiac events 30 days after procedure Secondary Objective: nd Timepoint(s) of evaluation of this end point: 30 days SECONDARY OUTCOME: Secondary end point(s): 1. Evaluation of peri‐procedural residual platelet reactivity. ; 2. Incidence of stent thrombosis at 30‐days follow‐up ; 3. Incidence of bleeding complications according to the criteria TIMI (major bleeding: intracranial hemorrhage, or associated with a decrease in hemoglobin of 5 g / dL; minor bleeding: reduction of hemoglobin <5 g / dl) or access site complications (hematoma more of 10 cm, or femoral artery pseudoaneurysm arteriovenous fistulas). ; 4. Evaluation of the expression of micro‐RNA pre‐and post‐procedure in the four treatment arms. Timepoint(s) of evaluation of this end point: 30 days INCLUSION CRITERIA: Unstable angina or non ST‐elevation myocardial infarction undergoing coronary angioplasty, already treated with clopidogrel in combination with aspirin at the time of the procedure (chronic therapy with 75 mg / day for at least 5 days, 300 mg loading at least 12 hours, load of 600 mg of at least 6 hours). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20