The purpose of this study is to explore the benefit of the prasugrel monotherapy without aspirin as compared with the 1-month dual therapy with aspirin and prasugrel in terms of reducing bleeding events after percutaneous coronary intervention (PCI) using cobalt-chromium everolimus-eluting stents (CoCr-EES, XienceTM) in patients with high bleeding risk or under the acute coronary syndrome patients.
In the previous trial, 1-month dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy provided a net clinical benefit for the cardiovascular and bleeding events over 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. However, even with very short DAPT, the rate of bleeding at 1-year remained very high in other trials that enrolled the patients with high bleeding risk (HBR). Notably, the risk of bleeding in patients with high bleeding risk (HBR) was particularly high within 1-month after percutaneous coronary intervention (PCI) in previous cohort data, when DAPT is implemented even in very short DAPT regimen. More recently, in another trial, prasugrel monotherapy without aspirin immediately after successful stent implantation was associated with no stent thrombosis in selected patients with low risk stable coronary artery disease. Aspirin-free strategy might be particularly beneficial in reducing bleeding in HBR patients. Patients with acute coronary syndrome (ACS) are also reported to be associated with higher risk for bleeding. Therefore, we have planned a study to compare the cardiovascular and bleeding events at 1-month after PCI using CoCr-EES between no DAPT strategy and 1-month DAPT strategy in patients with HBR or ACS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6,002
1-month prasugrel monotherapy followed by clopidogrel monotherapy
1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy
Kyoto University Graduate School of Medicine
Kyoto, Japan
Major bleeding
Bleeding defined as BARC criteria 3 or 5
Time frame: 1 month
Cardiovascular composite endpoint
Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis
Time frame: 1 month
Death
Death from any cause
Time frame: 1 month
Death
Death from any cause
Time frame: 12 months
Cardiovascular death
Death from cardiac or vascular disease
Time frame: 1 month
Cardiovascular death
Death from cardiac or vascular disease
Time frame: 12 months
Myocardial infarction
Defined by arterial revascularization therapies study (ARTS) criteria
Time frame: 1 month
Myocardial infarction
Defined by arterial revascularization therapies study (ARTS) criteria
Time frame: 12 months
Stroke
Including both ischemic and hemorrhagic stroke
Time frame: 1 month
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Stroke
Including both ischemic and hemorrhagic stroke
Time frame: 12 months
Ischemic stroke
Ischemic stroke with symptom lasting over 24 hours
Time frame: 1 month
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
Time frame: 1 month
Hemorrhagic stroke
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
Time frame: 12 months
Stent thrombosis
Stent thrombosis defined by Academic Research Consortium definition
Time frame: 1 month
Stent thrombosis
Stent thrombosis defined by Academic Research Consortium definition
Time frame: 12 months
Target lesion failure
The angiographical confirmation of the restenosis of the target lesions
Time frame: 1 month
Target lesion failure
The angiographical confirmation of the restenosis of the target lesions
Time frame: 12 months
Target vessel failure
The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels
Time frame: 1 month
Target vessel failure
The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels
Time frame: 12 months
Any target lesion revascularization
Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting
Time frame: 1 month
Any target lesion revascularization
Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting
Time frame: 12 months
Clinically-driven target lesion revascularization
Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Time frame: 1 month
Clinically-driven target lesion revascularization
Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Time frame: 12 months
Non-target lesions revascularization
Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
Time frame: 1 month
Non-target lesions revascularization
Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
Time frame: 12 months
Coronary artery bypass grafting
Any coronary artery bypass grafting
Time frame: 1 month
Coronary artery bypass grafting
Any coronary artery bypass grafting
Time frame: 12 months
Any target vessel revascularization
Revascularization to the target vessel
Time frame: 1 month
Any target vessel revascularization
Revascularization to the target vessel
Time frame: 12 months
Any coronary revascularization
Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
Time frame: 1 month
Any coronary revascularization
Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
Time frame: 12 months
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 2 bleeding defined by BARC criteria
Time frame: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
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: 1 month
Intracranial bleeding
Intracranial bleeding regardless of spontaneous or trauma
Time frame: 12 months
Gastrointestinal bleeding
Bleeding from gastrointestinal tract regardless of severity
Time frame: 1 month
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: 1 month
Gastrointestinal complaints
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Time frame: 12 months