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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,133
- 试验地点
- 1
- 主要终点
- The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients for whom use of Esomezol Cap is prohibited
研究组 & 干预措施
12-hour interval group (No interventional)
DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours
干预措施: Esomezol Cap (Drug)
co-administration group (No interventional)
Taking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time
干预措施: Esomezol Cap (Drug)
结局指标
主要结局
The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline
时间窗: 6 months
次要结局
- 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)