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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-18

Study Completion Date

2022-06-22

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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12-hour interval group (No interventional)

DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours

Esomezol Cap

Intervention Type DRUG

Esomezol Cap, Once daily administered per the locally approved product information

co-administration group (No interventional)

Taking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time

Esomezol Cap

Intervention Type DRUG

Esomezol Cap, Once daily administered per the locally approved product information

Interventions

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Esomezol Cap

Esomezol Cap, Once daily administered per the locally approved product information

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age≥19
2. 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
3. Subject who can written informed consent voluntarily