PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Interventions
- Registration Number
- NCT05709626
- Lead Sponsor
- Kindai University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2258
- 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
- Patients taking anticoagulants
- Patients under 18 years old
- Patients with less than 1 year prognosis
- Patients participating in other intervention studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No aspirin (Prasugrel monotherapy) No aspirin (Prasugurel monotherapy) To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI). 12-month DAPT 12-month DAPT To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).
- Primary Outcome Measures
Name Time Method Major adverse cardiovascular events 12 months Composite of all-cause death, myocardial infarction, or stroke
- Secondary Outcome Measures
Name Time Method 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
Target vessel failure 12 months Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization
Ischemic stroke 12 months Ischemic stroke with symptom lasting over 24 hours
Target lesion failure 12 months Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization
Non-cardiovascular death 12 months Death from non-cardiovascular cause
Myocardial infarction (Periprocedual/ Spontaneous) 12 months Defined by the Academic Research Consortium (ARC)-2
Hemorrhagic stroke 12 months Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
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
Coronary artery bypass grafting 12 months Any coronary artery bypass grafting
Any coronary revascularization 12 months Revascularization regardless of PCI or CABG
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
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
Cardiovascular death 12 months Death from cardiovascular cause
Stroke (Ischemic/ Haemorrhagic) 12 months Including both ischemic and haemorrhagic stroke
Stent thrombosis 12 months Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition
Clinically-driven target lesion revascularization 12 months Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria 12 months Type 4 bleeding defined by BARC criteria
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria 12 months Major 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 complaints 12 months Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Any target vessel revascularization 12 months Revascularization to the target vessel
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 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria 12 months Type 5 bleeding defined by BARC criteria
Gastrointestinal bleeding 12 months Bleeding from gastrointestinal tract regardless of severity
Non-target lesion revascularization 12 months Revascularization to non-target lesions regardless PCI or CABG
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria 12 months Minor bleeding defined by TIMI criteria
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria 12 months Moderate bleeding defined by GUSTO criteria
Trial Locations
- Locations (1)
Kindai University Faculty of Medicine
🇯🇵Osakasayama, Osaka, Japan