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
Overview
- Phase
- Not Applicable
- Intervention
- Esomezol Cap
- Conditions
- Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 4133
- Locations
- 1
- Primary Endpoint
- The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Subject who can written informed consent voluntarily
Exclusion Criteria
- •Patients for whom use of Esomezol Cap is prohibited
Arms & Interventions
12-hour interval group (No interventional)
DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours
Intervention: Esomezol Cap
co-administration group (No interventional)
Taking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time
Intervention: Esomezol Cap
Outcomes
Primary Outcomes
The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
Time Frame: 6 months
Secondary Outcomes
- The incidence of MACCE by each of the following constituent variables(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)
- The incidence e of Major bleeding(6 months)
- The incidence of Minor bleeding(6 months)
- The incidence of GI Bleeding(6 months)
- 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)