ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study

Study Overview
=================
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.

Official Title
-----------------
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy Study After Everolimus-eluting Cobalt-chromium Stent-3

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: No aspirin
* Drug: 1-month DAPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No aspirin<br>To start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI. | Drug: No aspirin<br>* 1-month prasugrel monotherapy followed by clopidogrel monotherapy<br>|
| Active Comparator: 1-month DAPT<br>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. | Drug: 1-month DAPT<br>* 1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | Bleeding defined as BARC criteria 3 or 5 | 1 month | 
| Cardiovascular composite endpoint | Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death from any cause | 1 month | 
| Death | Death from any cause | 12 months | 
| Cardiovascular death | Death from cardiac or vascular disease | 1 month | 
| Cardiovascular death | Death from cardiac or vascular disease | 12 months | 
| Myocardial infarction | Defined by arterial revascularization therapies study (ARTS) criteria | 1 month | 
| Myocardial infarction | Defined by arterial revascularization therapies study (ARTS) criteria | 12 months | 
| Stroke | Including both ischemic and hemorrhagic stroke | 1 month | 
| Stroke | Including both ischemic and hemorrhagic stroke | 12 months | 
| Ischemic stroke | Ischemic stroke with symptom lasting over 24 hours | 1 month | 
| Ischemic stroke | Ischemic stroke with symptom lasting over 24 hours | 12 months | 
| Hemorrhagic stroke | Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma | 1 month | 
| Hemorrhagic stroke | Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma | 12 months | 
| Stent thrombosis | Stent thrombosis defined by Academic Research Consortium definition | 1 month | 
| Stent thrombosis | Stent thrombosis defined by Academic Research Consortium definition | 12 months | 
| Target lesion failure | The angiographical confirmation of the restenosis of the target lesions | 1 month | 
| Target lesion failure | The angiographical confirmation of the restenosis of the target lesions | 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 | 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 | 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 | 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 | 12 months | 
| Clinically-driven target lesion revascularization | Target lesion revascularization with the anginal symptoms or the positive test for ischemia | 1 month | 
| Clinically-driven target lesion revascularization | Target lesion revascularization with the anginal symptoms or the positive test for ischemia | 12 months | 
| Non-target lesions revascularization | Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting | 1 month | 
| Non-target lesions revascularization | Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting | 12 months | 
| Coronary artery bypass grafting | Any coronary artery bypass grafting | 1 month | 
| Coronary artery bypass grafting | Any coronary artery bypass grafting | 12 months | 
| Any target vessel revascularization | Revascularization to the target vessel | 1 month | 
| Any target vessel revascularization | Revascularization to the target vessel | 12 months | 
| Any coronary revascularization | Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting | 1 month | 
| Any coronary revascularization | Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting | 12 months | 
| Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2 bleeding defined by BARC criteria | 1 month | 
| Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2 bleeding defined by BARC criteria | 12 months | 
| Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 3 bleeding defined by BARC criteria | 1 month | 
| Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 3 bleeding defined by BARC criteria | 12 months | 
| Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 4 bleeding defined by BARC criteria | 1 month | 
| Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 4 bleeding defined by BARC criteria | 12 months | 
| Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 5 bleeding defined by BARC criteria | 1 month | 
| Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 5 bleeding defined by BARC criteria | 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 | 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 | 12 months | 
| Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major bleeding defined by TIMI criteria | 1 month | 
| Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major bleeding defined by TIMI criteria | 12 months | 
| Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Minor bleeding defined by TIMI criteria | 1 month | 
| Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Minor bleeding defined by TIMI criteria | 12 months | 
| Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major or minor defined by TIMI criteria | 1 month | 
| Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major or minor defined by TIMI criteria | 12 months | 
| Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Severe bleeding defined by GUSTO criteria | 1 month | 
| Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Severe bleeding defined by GUSTO criteria | 12 months | 
| Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Moderate bleeding defined by GUSTO criteria | 1 month | 
| Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Moderate bleeding defined by GUSTO criteria | 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 | 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 | 12 months | 
| Intracranial bleeding | Intracranial bleeding regardless of spontaneous or trauma | 1 month | 
| Intracranial bleeding | Intracranial bleeding regardless of spontaneous or trauma | 12 months | 
| Gastrointestinal bleeding | Bleeding from gastrointestinal tract regardless of severity | 1 month | 
| Gastrointestinal bleeding | Bleeding from gastrointestinal tract regardless of severity | 12 months | 
| Gastrointestinal complaints | Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints | 1 month | 
| Gastrointestinal complaints | Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stent, percutaneous coronary transluminal angioplasty, bleeding, antiplatelet agents