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.
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 Type
OBSERVATIONAL
Enrollment
4,133
Esomezol Cap, Once daily administered per the locally approved product information
Hanmi Pharmaceutical Company Limited
Seoul, South Korea
The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
Time frame: 6 months
The incidence of MACCE by each of the following constituent variables
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
Time frame: 6 months
The incidence e of Major bleeding
Major bleeding: intracranial hemorrhage, bleeding requiring a transfusion or A decrease in hemoglobin level ≥ 5 g/dL or a decrease in hematocrit ≥ 15%
Time frame: 6 months
The incidence of Minor bleeding
Minor bleeding: Any bleeding other than major bleeding
Time frame: 6 months
The incidence of GI Bleeding
GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT
Time frame: 6 months
Occurrence and aspect of adverse events(AEs)
Time frame: 6 months
Medication compliance evaluation
Time frame: 6 months
Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap
Time frame: 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
Time frame: baseline
Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction
Time frame: 6 months
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