An Observational Study to Evaluate the Incidence of MACCE According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding

Study Overview
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Brief Summary
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This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for the prevention of gastrointestinal bleeding.

Detailed Description
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This study was a multi-center, prospective, non-interventional, observational study of administering Esomezol Cap for the purpose of preventing gastrointestinal bleeding. Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the safety of Esomezol Cap. This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Official Title
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A Multi-center, Prospective Cohort, Observational Study to Evaluate the Incidence of Major Adverse Cardiocerebrovascular Events According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received Dual AntiPlatelet Therapy (DAPT) for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding

Conditions
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Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months

Intervention / Treatment
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* Drug: Esomezol Cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥19 Among patients who visited the hospital due to the onset or recurrence of acute coronary syndrome or cerebral infarction within 1 month prior to registration, patients who are expected to receive DAPT(Clopidogrel + Aspirin) for at least 6 months, in combination with Esomezol Cap for the purpose of preventing gastrointestinal bleeding Patients receiving or planning to receive treatment Subject who can written informed consent voluntarily Exclusion Criteria: 1) Patients for whom use of Esomezol Cap is prohibited

Ages Eligible for Study
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Minimum Age: 19 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 12-hour interval group (No interventional)<br>DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours | Drug: Esomezol Cap<br>* Esomezol Cap, Once daily administered per the locally approved product information<br>|
| co-administration group (No interventional)<br>Taking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time | Drug: Esomezol Cap<br>* Esomezol Cap, Once daily administered per the locally approved product information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of MACCE by each of the following constituent variables | MACCE: Death due to cardiovascular abnormalities, myocardial infarction, stroke (ischemic or hemorrhagic), Target vessel reperfusion (in case of repeated intervention or coronary artery bypass surgery), All other cardiovascular events requiring hospitalization | 6 months | 
| The incidence e of Major bleeding | Major bleeding: intracranial hemorrhage, bleeding requiring a transfusion or A decrease in hemoglobin level ≥ 5 g/dL or a decrease in hematocrit ≥ 15% | 6 months | 
| The incidence of Minor bleeding | Minor bleeding: Any bleeding other than major bleeding | 6 months | 
| The incidence of GI Bleeding | GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT | 6 months | 
| Occurrence and aspect of adverse events(AEs) |  | 6 months | 
| Medication compliance evaluation |  | 6 months | 
| Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap |  | baseline | 
| Drugs that are prescribed in combination other than DAPT(Clopidogrel + Aspirin) and Esomezol Cap for the treatment of patients with acute coronary syndrome or cerebral infarction |  | baseline | 
| Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction |  | 6 months |