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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 4133

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05545
    • Hanmi Pharmaceutical Company Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute Coronary Syndrome or B Cerebral Infarction requiring DAPT (Clopidogrel + Aspirin) for at least 6 months

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
12-hour interval group (No interventional); DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours	Drug: Esomezol Cap; 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	Drug: Esomezol Cap; Esomezol Cap, Once daily administered per the locally approved product information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2019
• Primary Completion (ACTUAL): June 22, 2022
• Study Completion (ACTUAL): June 22, 2022

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (ACTUAL): August 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Gastrointestinal Diseases; Hemorrhage; Brain Ischemia; Stroke; Brain Infarction; Infarction; Syndrome; Cerebral Infarction; Acute Coronary Syndrome; Gastrointestinal Hemorrhage
• Other Study ID Numbers: HM-ESO-OS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No