Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- No reflow using angiographic criteria
研究概览
简要总结
Aim of the study is to Investigate the potential role of oral nicorandil in preventing the No reflow phenomenon in anterior ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PPCI).
Assess whether nicorandil, a potassium channel activator, can effectively enhance myocardial perfusion in this specific clinical context.
- In a randomized controlled trial study
- All recruited patients were randomized to either the treatment or control group in a ratio of 1:1 using a computer-generated randomization sequence in relation to the order of participation in the study. Patients fulfilling the inclusion criteria and consenting to participate in the study were recruited.
详细描述
This is a randomized, controlled clinical trial designed to evaluate the efficacy of a single oral dose of nicorandil in preventing the no-reflow phenomenon in patients with anterior ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
Study Setting:
The study is conducted at the Cardiology Departments of Ain Shams University Hospitals and Misr University for Science and Technology Hospitals.
Study intervention:
Group A (Study Group): Receives a single oral dose of nicorandil 20 mg prior to PPCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome of the study was assessed by an interventional cardiologist blind to group allocation:
Final TIMI Final MBG
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients diagnosed with anterior ST-segment elevation myocardial infarction (STEMI).
- •Individuals scheduled for percutaneous coronary intervention (PPCI).
- •Presence of risk factors or indications for preventing the No reflow phenomenon.
- •Willingness and ability to comply with the study protocol.
- •Ability to provide informed consent for participation in the study.
排除标准
- •Known allergic reaction to oral nicorandil.
- •Concomitant use of medications that may interact with nicorandil.
- •Presence of contraindications to oral nicorandil such as hypotension, hepatic or renal impairment
- •Need for emergent coronary artery bypass grafting.
研究组 & 干预措施
Treatment
Received 20mg of oral nicorandil
干预措施: Nicorandil 20mg (Drug)
结局指标
主要结局
No reflow using angiographic criteria
时间窗: Intra procedural
Incidence of No reflow
次要结局
- Major adverse cardiovascular events(1 week from procedure)