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 (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05487560
• Collaborator: (none)
• Enrollment: 4,133
• Location: 1
• Actual Duration (Months): 38.1
• Patients Per Site Per Month: 108.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months	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 Design

• Study Type: Observational
• Actual Enrollment: 4133 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Apr 18, 2019
• Actual Primary Completion Date: Jun 22, 2022
• Actual Study Completion Date: Jun 22, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline [6 months]

Secondary Outcome Measures

1. 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

2. 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%

3. The incidence of Minor bleeding [6 months]

   Minor bleeding: Any bleeding other than major bleeding

4. The incidence of GI Bleeding [6 months]

   GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT

5. Occurrence and aspect of adverse events(AEs) [6 months]

6. Medication compliance evaluation [6 months]

7. Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap [baseline]

8. 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]

9. Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanmi Pharmaceutical Company Limited	Seoul		Korea, Republic of	05545

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT05487560
• Other Study ID Numbers: HM-ESO-OS-01
• First Posted: Aug 4, 2022
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Hemorrhage; Cerebral Infarction; Acute Coronary Syndrome; Syndrome; Infarction

Study Results

No Results Posted as of Aug 4, 2022