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

Sponsor

Kindai University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05709626

Collaborator

Boston Scientific Corporation (Industry)

2,258

Enrollment

Arms

59.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
ST-segment Elevation Myocardial Infarction (STEMI)	Drug: No aspirin (Prasugurel monotherapy) Drug: 12-month DAPT	Phase 4

Detailed 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 23, 2023

Anticipated Primary Completion Date :

Jan 4, 2025

Anticipated Study Completion Date :

Jan 4, 2028

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: No aspirin (Prasugrel monotherapy)

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

Drug: No aspirin (Prasugurel monotherapy)

12-month prasugrel monotherapy

Other Names:

Experimental arm

Active Comparator: 12-month DAPT

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

Drug: 12-month DAPT

12-month dual antiplatelet therapy with prasugrel and aspirin

Other Names:

Reference arm

Outcome Measures

Primary Outcome Measures

Major adverse cardiovascular events [12 months]
Composite of all-cause death, myocardial infarction, or stroke

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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