The NEOMINDSET trial is designed to test whether P2Y12 inhibitor monotherapy immediately following PCI is non-inferior to DAPT for ischemic events and superior for bleeding in ACS patients.
RCT
Does P2Y12 inhibitor monotherapy immediately following PCI with DES improve bleeding outcomes without increasing ischemic events compared to 12 months of dual antiplatelet therapy in patients with acute coronary syndromes?
The NEOMINDSET trial is designed to provide important insights on the efficacy and safety of withdrawing aspirin immediately after PCI with DES in the early phase of ACS.
inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).
Guimarães et al. (Sat,) conducted a rct in Acute coronary syndromes undergoing coronary stenting. P2Y12 inhibitor monotherapy (SAPT) vs. Dual antiplatelet therapy (DAPT) was evaluated on Composite of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation. The NEOMINDSET trial is designed to test whether P2Y12 inhibitor monotherapy immediately following PCI is non-inferior to DAPT for ischemic events and superior for bleeding in ACS patients.
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