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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2028-01-04

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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ST-segment Elevation Myocardial Infarction (STEMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No aspirin (Prasugrel monotherapy)

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

Group Type ACTIVE_COMPARATOR

No aspirin (Prasugurel monotherapy)

Intervention Type DRUG

12-month prasugrel monotherapy

12-month DAPT

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

Group Type ACTIVE_COMPARATOR

12-month DAPT

Intervention Type DRUG

12-month dual antiplatelet therapy with prasugrel and aspirin

Interventions

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No aspirin (Prasugurel monotherapy)

12-month prasugrel monotherapy

Intervention Type DRUG

12-month DAPT

12-month dual antiplatelet therapy with prasugrel and aspirin

Intervention Type DRUG

Other Intervention Names

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Experimental arm Reference arm

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No