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

Hanmi Pharmaceutical

Status: Completed

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

Treatments: Drug: Esomezol Cap

Study type: Observational

Funder types: Industry

Identifiers

NCT05487560

HM-ESO-OS-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,133 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. Patients for whom use of Esomezol Cap is prohibited

Trial design

4,133 participants in 2 patient groups

12-hour interval group (No interventional)

Description:

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

Treatment:

Drug: Esomezol Cap

co-administration group (No interventional)

Description:

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

Treatment:

Drug: Esomezol Cap