AIMS
To demonstrate the feasibility and safety of prasugrel monotherapy without aspirin post procedure in selected patients undergoing successful percutaneous coronary intervention (PCI) with the SYNERGY stent.
METHODS AND RESULTS
The ASET Pilot study is designed as a multicenter, single arm, open-label, proof-of-concept trial with a stopping rule based on the occurrence of definite stent thrombosis (def-ST). Two hundred patients with a SYNTAX score of <23 requiring PCI for stable angina or stabilized acute coronary syndrome with normal or decreasing cardiac enzyme will be screened and considered eligible for the study. After optimal SYNERGY stent implantation, patients will be enrolled and loaded with prasugrel 60 mg and continued with only prasugrel 10 mg once a day for 3 months. Therefore, Aspirin will be discontinued on the day following the index procedure. After 3 months, prasugrel will be replaced by standard of antiplatelet therapy according to local practice. The primary ischemic endpoint is a composite of cardiac death, target-vessel myocardial infarction or def-ST, whereas the primary bleeding endpoint is any Bleeding Academic Research Consortium type 3 and 5 bleeding up to 3 months. If more than 3 cases of def-ST occur during follow-up, the patient recruitment will be terminated.
CONCLUSIONS
Favourable results would justify a subsequent investigational phase testing the same treatment strategy and proof of concept in patients with Non-ST-elevation myocardial infarction and ST-elevation myocardial infarction.