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

Completed

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

• Registration Number: NCT05487560
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-18
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Status Verified: 2022-08
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4133

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
12-hour interval group (No interventional)	Esomezol Cap	DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours
co-administration group (No interventional)	Esomezol Cap	Taking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time

Primary Outcome Measures

Name	Time	Method
The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline	6 months

Secondary Outcome Measures

Name	Time	Method
Occurrence and aspect of adverse events(AEs)	6 months
Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction	6 months
The incidence of MACCE by each of the following constituent variables	6 months	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
Medication compliance evaluation	6 months
Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap	baseline
The incidence e of Major bleeding	6 months	Major bleeding: intracranial hemorrhage, bleeding requiring a transfusion or A decrease in hemoglobin level ≥ 5 g/dL or a decrease in hematocrit ≥ 15%
The incidence of Minor bleeding	6 months	Minor bleeding: Any bleeding other than major bleeding
The incidence of GI Bleeding	6 months	GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT
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

Trial Locations

Locations (1)

Hanmi Pharmaceutical Company Limited; 🇰🇷 Seoul, Korea, Republic of