ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study
- Conditions
- Acute Coronary Syndrome
- Interventions
- Registration Number
- NCT04609111
- Lead Sponsor
- Kyoto University, Graduate School of Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 6002
- Patients who are planned to have percutaneous coronary intervention with exclusive use of everolimus-eluting stent (XienceTM series).
- Patients with high bleeding risk defined by Academic Research Consortium or acute coronary syndrome
- Patients who could take dual antiplatelet therapy with aspirin and P2Y12 inhibitors for 1-month
- Patients who are judged to be unsuitable for participation by the principal investigator and co-investigator
- Patients with a known allergy to the study drugs
- Patients enrolled in the ongoing prospective interventional studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1-month DAPT 1-month DAPT To start dual antiplatelet therapy comprising of aspirin and prasugrel before the index percutaneous coronary intervention (PCI) and to change into aspirin monotherapy at 1-month after the PCI. No aspirin No aspirin To start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI.
- Primary Outcome Measures
Name Time Method Major bleeding 1 month Bleeding defined as BARC criteria 3 or 5
Cardiovascular composite endpoint 1 month Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis
- Secondary Outcome Measures
Name Time Method Death 12 months Death from any cause
Intracranial bleeding 12 months Intracranial bleeding regardless of spontaneous or trauma
Cardiovascular death 12 months Death from cardiac or vascular disease
Myocardial infarction 12 months Defined by arterial revascularization therapies study (ARTS) criteria
Stroke 12 months Including both ischemic and hemorrhagic 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 definition
Target lesion failure 12 months The angiographical confirmation of the restenosis of the target lesions
Target vessel failure 12 months The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels
Any target lesion revascularization 12 months Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting
Clinically-driven target lesion revascularization 12 months Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Non-target lesions revascularization 12 months Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
Coronary artery bypass grafting 12 months Any coronary artery bypass grafting
Any target vessel revascularization 12 months Revascularization to the target vessel
Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria 12 months Severe bleeding defined by GUSTO criteria
Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria 12 months Moderate bleeding defined by GUSTO 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
Any coronary revascularization 12 months Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
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
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
Trial Locations
- Locations (1)
Kyoto University Graduate School of Medicine
🇯🇵Kyoto, Japan