OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet
therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation
Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes
(composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major
bleeding at 18 months after randomization).
The trial will incorporate two registers studying respectively the safety outcomes of
Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30
days. Finally the trial design permits assessment of the clinical outcomes after primary PCI
for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent
at 30 days and 6 months.