Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT05487560
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Hanmi Pharmaceutical Company Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: