STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT (STARS DAPT)
ST Elevation Myocardial Infarction
About this trial
This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Single antiplatelet therapy, P2Y12 receptor inhibitor, ST-segment elevation myocardial infarction, Polymer-free drug-eluting stent
Eligibility Criteria
Inclusion Criteria: Age ≥18 years. Subject with acute STEMI planned to undergo primary PCI according to ESC guidelines. Subjects with ≥1 acute infarct artery target vessel with ≥1 coronary artery stenosis in a native coronary artery with diameter from 2.25 to 4.0 mm that can be treated with ≥1 coronary stent. Subject who underwent successful primary PCI, defined as primary PCI with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation, and final residual stenosis <30% by visual estimation or 20% by QCA (quantitative coronary angiography) (28). Subject willing to participate and able to understand, read and sign the informed consent document after the primary PCI procedure. Exclusion Criteria: Contraindications to PCI and/or DES implantation. Known allergy to aspirin, ticagrelor, prasugrel, or sirolimus. Inability to adhere to DAPT for at least 6 months. Patient already on DAPT at index presentation due to recent PCI (<6 months) or ACS (<12 months). Patient on chronic oral anticoagulation at index presentation. Patient with mechanical complication of STEMI. Patient with acute STEMI due to stent thrombosis. Planned non-cardiac surgery that cannot be postponed for at least 6 months. Participation or planned participation in another clinical trial, except for observational registries. Life expectancy <1 years. Pregnancy.
Sites / Locations
- Geneva University Hospitals
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Potent P2Y12 receptor inhibitor-based single antiplatelet therapy (SAPT)
Conventional dual antiplatelet therapy (DAPT)
P2Y12 receptor inhibitor-based SAPT with ticagrelor (90 mg bd) or prasugrel (10 mg od, or 5 mg in patients ≥75 years or with a body weight <60 kg), at the discretion of the investigator, during 12 months after the index procedure. Clopidogrel-based SAPT will not be allowed. Aspirin will be discontinued after primary PCI, or at latest at hospital discharge.
DAPT combining aspirin (≥75 mg od) and a potent P2Y12 receptor inhibitor, either ticagrelor (90 mg bd) or prasugrel (10 mg od, or 5 mg in patients ≥75 years or with a body weight <60 kg), at the discretion of the investigator, during 6 or 12 months after the index procedure, followed by aspirin-based SAPT. Clopidogrel (75 mg od orally) will be allowed if ticagrelor or prasugrel are contra-indicated or not available.