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

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

— PREMIUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709626
• Other study ID #: Y0140
• Status: Recruiting
• Phase: Phase 4
• Start date: February 28, 2023
• Est. completion date: January 4, 2028

Study information

• Verified date: February 2023
• Source: Kindai University
• Contact: Kuniaki Takahashi, MD, PhD
• Phone: +81-72-366-0221
• Email: kuniaki.t.0125[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2258
• Est. completion date: January 4, 2028
• Est. primary completion date: January 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Intervention

Drug:
• No aspirin (Prasugurel monotherapy)
12-month prasugrel monotherapy
• 12-month DAPT
12-month dual antiplatelet therapy with prasugrel and aspirin

Locations

Country	Name	City	State
Japan	Kindai University Faculty of Medicine	Osakasayama	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Kindai University	Boston Scientific Corporation

Country where clinical trial is conducted

Japan, 

Outcome

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