Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 4133
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Coronary Syndrome or B Cerebral Infarction requiring DAPT (Clopidogrel + Aspirin) for at least 6 months

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
timeFrame: 6 months
Secondary outcomes:
measure: The incidence of MACCE by each of the following constituent variables
timeFrame: 6 months
measure: The incidence e of Major bleeding
timeFrame: 6 months
measure: The incidence of Minor bleeding
timeFrame: 6 months
measure: The incidence of GI Bleeding
timeFrame: 6 months
measure: Occurrence and aspect of adverse events(AEs)
timeFrame: 6 months
measure: Medication compliance evaluation
timeFrame: 6 months
measure: Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap
timeFrame: baseline
measure: 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
timeFrame: baseline
measure: Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Pharmaceutical Company Limited
Study officials:
References: