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

Study Overview
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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).

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).

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

Conditions
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ST-segment Elevation Myocardial Infarction (STEMI)

Intervention / Treatment
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* Drug: No aspirin (Prasugurel monotherapy)
* Drug: 12-month DAPT


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No aspirin (Prasugrel monotherapy)<br>To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI). | Drug: No aspirin (Prasugurel monotherapy)<br>* 12-month prasugrel monotherapy<br>* Other names: Experimental arm;|
| Active Comparator: 12-month DAPT<br>To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI). | Drug: 12-month DAPT<br>* 12-month dual antiplatelet therapy with prasugrel and aspirin<br>* Other names: Reference arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | Composite of all-cause death, myocardial infarction, or stroke | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 3 or 5 bleeding defined by BARC criteria | 12 months | 
| All-cause death | Death from any cause | 12 months | 
| Cardiovascular death | Death from cardiovascular cause | 12 months | 
| Non-cardiovascular death | Death from non-cardiovascular cause | 12 months | 
| Myocardial infarction (Periprocedual/ Spontaneous) | Defined by the Academic Research Consortium (ARC)-2 | 12 months | 
| Stroke (Ischemic/ Haemorrhagic) | Including both ischemic and haemorrhagic stroke | 12 months | 
| Ischemic stroke | Ischemic stroke with symptom lasting over 24 hours | 12 months | 
| Hemorrhagic stroke | Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma | 12 months | 
| Stent thrombosis | Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition | 12 months | 
| Target lesion failure | Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization | 12 months | 
| Target vessel failure | Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization | 12 months | 
| Patient-Oriented Composite Endpoint | All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2 | 12 months | 
| Any target lesion revascularization | Revascularization to the target lesions (including 5mm of both ends of the stent[s]) regardless of PCI or CABG | 12 months | 
| Clinically-driven target lesion revascularization | Target lesion revascularization with the anginal symptoms or the positive test for ischemia | 12 months | 
| Non-target lesion revascularization | Revascularization to non-target lesions regardless PCI or CABG | 12 months | 
| Coronary artery bypass grafting | Any coronary artery bypass grafting | 12 months | 
| Any target vessel revascularization | Revascularization to the target vessel | 12 months | 
| Any coronary revascularization | Revascularization regardless of PCI or CABG | 12 months | 
| Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2 bleeding defined by BARC criteria | 12 months | 
| Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 3 bleeding defined by BARC criteria | 12 months | 
| Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 4 bleeding defined by BARC criteria | 12 months | 
| Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 5 bleeding defined by BARC criteria | 12 months | 
| Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2, 3, or 5 bleeding defined by BARC criteria | 12 months | 
| Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major bleeding defined by TIMI criteria | 12 months | 
| Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Minor bleeding defined by TIMI criteria | 12 months | 
| Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major or minor defined by TIMI criteria | 12 months | 
| Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria | Severe bleeding defined by GUSTO criteria | 12 months | 
| Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria | Moderate bleeding defined by GUSTO criteria | 12 months | 
| Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria | Moderate or severe bleeding defined by GUSTO criteria | 12 months | 
| Intracranial bleeding | Intracranial bleeding regardless of spontaneous or trauma | 12 months | 
| Gastrointestinal bleeding | Bleeding from gastrointestinal tract regardless of severity | 12 months | 
| Gastrointestinal complaints | Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Dual AntiPlatelet Therapy, Drug Eluting Stent, Percutaneous Coronary Intervention, ST-elevation myocardial infarction