Clinical trial NCT05709626: PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
Official title: PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: Acute Coronary Syndrome
Dual AntiPlatelet Therapy
Drug Eluting Stent
Percutaneous Coronary Intervention
ST-elevation myocardial infarction
Lead sponsor: Kindai University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2023-02-02
Enrollment: 2258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 12 months
Secondary outcomes:
measure: Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: All-cause death
timeFrame: 12 months
measure: Cardiovascular death
timeFrame: 12 months
measure: Non-cardiovascular death
timeFrame: 12 months
measure: Myocardial infarction (Periprocedual/ Spontaneous)
timeFrame: 12 months
measure: Stroke (Ischemic/ Haemorrhagic)
timeFrame: 12 months
measure: Ischemic stroke
timeFrame: 12 months
measure: Hemorrhagic stroke
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Target lesion failure
timeFrame: 12 months
measure: Target vessel failure
timeFrame: 12 months
measure: Patient-Oriented Composite Endpoint
timeFrame: 12 months
measure: Any target lesion revascularization
timeFrame: 12 months
measure: Clinically-driven target lesion revascularization
timeFrame: 12 months
measure: Non-target lesion revascularization
timeFrame: 12 months
measure: Coronary artery bypass grafting
timeFrame: 12 months
measure: Any target vessel revascularization
timeFrame: 12 months
measure: Any coronary revascularization
timeFrame: 12 months
measure: Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 12 months
measure: Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 12 months
measure: Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 12 months
measure: Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
timeFrame: 12 months
measure: Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
timeFrame: 12 months
measure: Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
timeFrame: 12 months
measure: Intracranial bleeding
timeFrame: 12 months
measure: Gastrointestinal bleeding
timeFrame: 12 months
measure: Gastrointestinal complaints
timeFrame: 12 months
Other outcomes:
Locations:
city: Osakasayama
country: Japan
facility: Kindai University Faculty of Medicine
state: Osaka
Study officials:
affiliation: Kindai University Faculty of Medicine
name: Gaku Nakazawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: