ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With ACS

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES) under the setting of acute coronary syndrome (ACS).

Detailed Description
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The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. Especially guidelines recommend 1-year DAPT for patients with acute coronary syndrome (ACS), though its rational is based on the study more than 15 years old. However, serious hemorrhagic complications associated with prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. The investigators already planned and started a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be divided into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group (STOPDAPT-2; NCT02619760), where primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. In STOPDAPT-2, the non-inferiority about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure. The proportion of patients with ACS is about 30-40% in STOPDAPT-2 and the power is insufficient to evaluate the safety and efficacy of 1-month DAPT regimen specifically for patients with ACS. Therefore the investigators planned the current study to enroll patients of ACS with the same protocol as STOPDAPT-2.

Official Title
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Study to Evaluate the Safety of Reducing Dual Antiplatelet Therapy (DAPT) Duration to 1 Month for Patients With Acute Coronary Syndrome (ACS) After Implantation of Everolimus-eluting Cobalt-chromium Stent

Conditions
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Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors

Intervention / Treatment
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* Drug: 1-months DAPT
* Drug: 12-month DAPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent under the setting of acute coronary syndrome Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and P2Y12 receptor antagonist Exclusion Criteria: Patients requiring oral anticoagulants Patients with medical history of intracranial hemorrhage Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents implanted at the time of enrollment Patients confirmed to have no tolerability to clopidogrel before enrollment Patients requiring continuous administration of antiplatelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-month DAPT<br>1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months | Drug: 1-months DAPT<br>* 1-month DAPT followed by 59-month monotherapy<br>|
| Active Comparator: 12-month DAPT<br>1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists; 11-month DAPT composed of aspirin and clopidogrel and aspirin monotherapy for 48 months | Drug: 12-month DAPT<br>* 12-month DAPT followed by 48-month monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group |  | 12 months | 
| Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke |  | 12 months | 
| Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke |  | 60 months | 
| Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group |  | 12 months | 
| Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group |  | 60 months | 
| Upper gastrointestinal endoscopic examination or treatment |  | 60 months | 
| Composite event of all-cause death/myocardial infarction |  | 12 months | 
| Composite event of all-cause death/myocardial infarction |  | 60 months | 
| All-cause death |  | 12 months | 
| All-cause death |  | 60 months | 
| Composite event of cardiovascular death/myocardial infarction |  | 12 months | 
| Composite event of cardiovascular death/myocardial infarction |  | 60 months | 
| Cardiovascular death |  | 12 months | 
| Cardiovascular death |  | 60 months | 
| Myocardial infarction |  | 12 months | 
| Myocardial infarction |  | 60 months | 
| Stroke |  | 12 months | 
| Stroke |  | 60 months | 
| Definite stent thrombosis | Academic Research Consortium definition | 12 months | 
| Definite stent thrombosis | Academic Research Consortium definition | 60 months | 
| Target lesion failure |  | 12 months | 
| Target lesion failure |  | 60 months | 
| Target vessel failure |  | 12 months | 
| Target vessel failure |  | 60 months | 
| Major adverse cardiac event | Composite of cardiac death, myocardial infarction, and clinically-driven TLR | 12 months | 
| Major adverse cardiac event | Composite of cardiac death, myocardial infarction, and clinically-driven TLR | 60 months | 
| Target lesion revascularization |  | 12 months | 
| Target lesion revascularization |  | 60 months | 
| Clinically-driven target lesion revascularization |  | 12 months | 
| Clinically-driven target lesion revascularization |  | 60 months | 
| Non target lesion revascularization |  | 12 months | 
| Non target lesion revascularization |  | 60 months | 
| Coronary artery bypass graft |  | 12 months | 
| Coronary artery bypass graft |  | 60 months | 
| Target vessel revascularization |  | 12 months | 
| Target vessel revascularization |  | 60 months | 
| Any coronary revascularization |  | 12 months | 
| Any coronary revascularization |  | 60 months | 
| Bleeding complications |  | 12 months | 
| Bleeding complications |  | 60 months | 
| Gastrointestinal bleeding |  | 12 months | 
| Gastrointestinal bleeding |  | 60 months | 
| Gastrointestinal complaints requiring upper gastrointestinal endoscopy |  | 12 months | 
| Gastrointestinal complaints requiring upper gastrointestinal endoscopy |  | 60 months | 
| Newly diagnosed cancer | The endpoint is a newly diagnosed malignancy during the follow-up period that has not been previously diagnosed before enrollment. This does not include recurrent tumor after remission, includes early-stage cancer eligible for endoscopic treatment, and includes the tumors which are not diagnosed by tissue biopsy but are judged to be clinically malignant on imaging. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors