Key result
RCT tests upfront prasugrel monotherapy versus 12-month DAPT in STEMI patients undergoing PCI.
Why the study?
Although P2Y12 inhibitor monotherapy after 1-3 months of DAPT is safe following PCI in acute coronary syndromes, the safety of initiating prasugrel monotherapy at the time of primary PCI in STEMI patients remained unknown.
Does upfront prasugrel monotherapy initiated before primary PCI demonstrate noninferiority for ischemic outcomes (all-cause death, MI, or stroke) and superiority in reducing major bleeding compared with standard 12-month DAPT in East Asian STEMI patients undergoing imaging-guided PCI?
RCT (n=2,268)
Open-label
1:1
Yes
Does upfront prasugrel monotherapy initiated before primary PCI demonstrate noninferiority for ischemic outcomes (all-cause death, MI, or stroke) and superiority in reducing major bleeding compared with standard 12-month DAPT in East Asian STEMI patients undergoing imaging-guided PCI?
The PREMIUM trial is the first large-scale randomized study designed to evaluate the noninferiority for ischemic outcomes and superiority for major bleeding of an upfront aspirin-free prasugrel monotherapy strategy versus 12-month DAPT in East Asian STEMI patients undergoing imaging-guided primary PCI.
Background Previous randomized trials have demonstrated the safety of P2Y12 inhibitor monotherapy after 1-3 months of dual antiplatelet therapy (DAPT) compared with 12-month DAPT following percutaneous coronary intervention (PCI) in patients with acute coronary syndromes. However, the safety of initiating prasugrel monotherapy at the time of primary PCI in patients presenting with ST-segment elevation myocardial infarction (STEMI) remains unknown. Methods/design The PREMIUM (Prasugrel monotherapy following primary percutaneous coronary intervention for ST-elevation myocardial infarction) trial is an investigator-initiated, open-label, multicenter randomized controlled trial. A total of 2268 STEMI patients indicated for primary PCI with current generation platinum‑chromium everolimus-eluting stents were randomized 1:1 to either prasugrel monotherapy (20 mg loading, 3.75 mg daily) initiated before PCI or standard 12-month DAPT with aspirin plus prasugrel. The primary endpoint is a composite of all-cause death, myocardial infarction, or stroke at 12 months tested for noninferiority. The major secondary endpoint is Bleeding Academic Research Consortium type 3 or 5 bleeding at 12 months tested for superiority. Summary The PREMIUM trial is the first large-scale randomized study to evaluate an upfront aspirin-free strategy with prasugrel monotherapy compared with standard 12-month DAPT in STEMI undergoing contemporary imaging-guided PCI. The trial is designed to determine noninferiority for ischemic outcomes and to assess superiority in reducing major bleeding at 12 months in East Asian patients. Trial registration NCT05709626; jRCTs052220145.
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Takahashi et al. (2025) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=2,268). Prasugrel monotherapy initiated before PCI vs. Standard 12-month DAPT with aspirin plus prasugrel was evaluated on Composite of all-cause death, myocardial infarction, or stroke at 12 months. Upfront prasugrel monotherapy (20 mg load, 3.75 mg daily) is being tested for noninferiority against 12-month DAPT in 2,268 STEMI patients undergoing PCI (design paper; outcomes pending).
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