PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction (PREMIUM)

Kindai University

Status and phase: Enrolling; Phase 4

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Treatments: Drug: 12-month DAPT; Drug: No aspirin (Prasugurel monotherapy)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05709626

Y0140

Details and patient eligibility

About

The aim of this study is to evaluate the safety of prasugrel monotherapy without aspirin versus 12-month dual antiplatelet therapy (DAPT) in patients with STEMI using platinum-chrome everolimus-eluting stent (PtCr-EES: SYNERGYTM).

Full description

In the STOPDAPT-2 ACS trial (NCT03462498), ischemic events (especially myocardial infarction) was significantly increased with 1-month DAPT followed by clopidogrel monotherapy, as compared to 12-month DAPT in patients with acute coronary syndrome (ACS). This was potentially attributable to clopidogrel, instead of prasugrel, which is more potent and has less individual difference in efficacy. On the other hand, previous studies including the STOPDAPT-2 ACS that evaluated the safety and efficacy of monotherapy with a P2Y12 inhibitor without aspirin consistently and significantly reduced the risk of bleeding, compared with standard DAPT. Consequently, there has been growing necessity to establish the safety with P2Y12 inhibitor monotherapy in terms of major adverse cardiovascular events. Therefore, we have planned to evaluate the non-inferiority of P2Y12 inhibitor monotherapy with prasugrel versus standard 12-month DAPT with prasugrel and aspirin in terms of the incidence of major cardiovascular events at 12 months after primary PCI in patients with STEMI using Platinum-Chromium Everolimus Eluting Stent (PtCr-EES; SYNERGYTM).

Enrollment: 2,258 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGYTM)
• STEMI patients
• Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months

Exclusion criteria

• Patients taking anticoagulants
• Patients under 18 years old
• Patients with less than 1 year prognosis
• Patients participating in other intervention studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,258 participants in 2 patient groups

No aspirin (Prasugrel monotherapy)

Active Comparator group

Description:

To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI).

Treatment:

Drug: No aspirin (Prasugurel monotherapy)

12-month DAPT

Active Comparator group

Description:

To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).

Treatment:

Drug: 12-month DAPT