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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,258
12-month prasugrel monotherapy
12-month dual antiplatelet therapy with prasugrel and aspirin
Kindai University Faculty of Medicine
Sayama, Osaka, Japan
RECRUITINGMajor adverse cardiovascular events
Composite of all-cause death, myocardial infarction, or stroke
Time frame: 12 months
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
Time frame: 12 months
All-cause death
Death from any cause
Time frame: 12 months
Cardiovascular death
Death from cardiovascular cause
Time frame: 12 months
Non-cardiovascular death
Death from non-cardiovascular cause
Time frame: 12 months
Myocardial infarction (Periprocedual/ Spontaneous)
Defined by the Academic Research Consortium (ARC)-2
Time frame: 12 months
Stroke (Ischemic/ Haemorrhagic)
Including both ischemic and haemorrhagic stroke
Time frame: 12 months
Ischemic stroke
Ischemic stroke with symptom lasting over 24 hours
Time frame: 12 months
Hemorrhagic stroke
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
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Time frame: 12 months
Stent thrombosis
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition
Time frame: 12 months
Target lesion failure
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization
Time frame: 12 months
Target vessel failure
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization
Time frame: 12 months
Patient-Oriented Composite Endpoint
All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2
Time frame: 12 months
Any target lesion revascularization
Revascularization to the target lesions (including 5mm of both ends of the stent\[s\]) regardless of PCI or CABG
Time frame: 12 months
Clinically-driven target lesion revascularization
Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Time frame: 12 months
Non-target lesion revascularization
Revascularization to non-target lesions regardless PCI or CABG
Time frame: 12 months
Coronary artery bypass grafting
Any coronary artery bypass grafting
Time frame: 12 months
Any target vessel revascularization
Revascularization to the target vessel
Time frame: 12 months
Any coronary revascularization
Revascularization regardless of PCI or CABG
Time frame: 12 months
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 2 bleeding defined by BARC criteria
Time frame: 12 months
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 3 bleeding defined by BARC criteria
Time frame: 12 months
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 4 bleeding defined by BARC criteria
Time frame: 12 months
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 5 bleeding defined by BARC criteria
Time frame: 12 months
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 2, 3, or 5 bleeding defined by BARC criteria
Time frame: 12 months
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Major bleeding defined by TIMI criteria
Time frame: 12 months
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Minor bleeding defined by TIMI criteria
Time frame: 12 months
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Major or minor defined by TIMI criteria
Time frame: 12 months
Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Severe bleeding defined by GUSTO criteria
Time frame: 12 months
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Moderate bleeding defined by GUSTO criteria
Time frame: 12 months
Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Moderate or severe bleeding defined by GUSTO criteria
Time frame: 12 months
Intracranial bleeding
Intracranial bleeding regardless of spontaneous or trauma
Time frame: 12 months
Gastrointestinal bleeding
Bleeding from gastrointestinal tract regardless of severity
Time frame: 12 months
Gastrointestinal complaints
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Time frame: 12 months