NCT05487560

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,133 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Esomezol Cap	Esomezol Cap, Once daily administered per the locally approved product information

Timeline

• Start date: 2019-04-18
• Primary completion: 2022-06-22
• Completion: 2022-06-22
• First posted: 2022-08-04
• Last updated: 2022-08-04

Locations

1 site across 1 country: South Korea