Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months
Conditions
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.
Interventions
DRUGEsomezol Cap
Esomezol Cap, Once daily administered per the locally approved product information
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| The incidence of Minor bleeding | 6 months | Minor bleeding: Any bleeding other than major bleeding |
| The incidence of GI Bleeding | 6 months | GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT |
| Occurrence and aspect of adverse events(AEs) | 6 months | — |
| 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 |
| Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap | baseline | — |
| 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 | — |
| Medication compliance evaluation | 6 months | — |
Countries
South Korea
Outcome results
None listed