ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
Acute Coronary Syndrome, Dual AntiPlatelet Therapy, Drug Eluting Stent, Percutaneous Coronary Intervention, ST-elevation myocardial infarction
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).
Interventions
DRUGNo aspirin (Prasugurel monotherapy)
12-month prasugrel monotherapy
DRUG12-month DAPT
12-month dual antiplatelet therapy with prasugrel and aspirin
Sponsors
Boston Scientific Corporation
Kindai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | 12 months | Composite of all-cause death, myocardial infarction, or stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria | 12 months | Moderate bleeding defined by GUSTO criteria |
| 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 |
| 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 |
| Clinically-driven target lesion revascularization | 12 months | Target lesion revascularization with the anginal symptoms or the positive test for ischemia |
Countries
Japan
Contacts
Primary ContactKuniaki Takahashi, MD, PhD
Outcome results
None listed