The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury in Patients With ST-Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: Study on NLRP3, ASC, Caspase, and Troponin
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Rate of Myocardial Reperfusion Injury
研究概览
简要总结
The goal of this clinical trial is to investigate the role of colchicine in reducing the rate of myocardial reperfusion injury in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention. The main questions it aims to answer are:
- Does colchicine reduce the rate of myocardial reperfusion injury ?
- Does colchicine reduce the concentration of markers of myocardial reperfusion injury (NLRP3, ASC, caspase, and troponin) ?
Participants will
- Be grouped into intervention group and control group blindly. Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days. Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.
- Undergo peripheral blood vein examination before primary percutaneous coronary intervention, after primary percutaneous coronary intervention, 24 hour after primary percutaneous coronary intervention, and 48 hour after primary percutaneous coronary intervention.
Researchers will compare intervention group and control group to see if colchicine reduces the rate of myocardial reperfusion injury and reduces the concentration of markers of myocardial reperfusion injury (NLRP3, ASC, caspase, and troponin) in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Colchicine and placebo (lactose) will be packed in capsules with the same appearance by the pharmacist. The pharmacist will code the capsules containing colchicine or the capsules containing placebo into group A or group B without informing the participant, care provider, investigator, and outcome assessor regarding the content of each group of capsules. Participant, care provider, investigator, and outcome assessor do not know the content of the capsules given to the participants.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ST-elevation myocardial infarction based on clinical symptoms, signs, and electrocardiography who undergo primary percutaneous coronary intervention
- •Patients aged 18 - 80 years old
排除标准
- •Patients with malignancy
- •Patients with allergic reaction to colchicine
- •Stroke within the last 3 months
- •Severe infection (sepsis)
- •Chronic kidney disease with eGFR of <30mL/min/1.73m2
研究组 & 干预措施
Colchicine
Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days.
干预措施: Colchicine (Drug)
Placebo
Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.
干预措施: Placebo (lactose) (Drug)
结局指标
主要结局
The Rate of Myocardial Reperfusion Injury
时间窗: Up to 3 days after primary percutaneous coronary intervention
The rate of hypotension, acute heart failure, arrhythmias, persistent chest pain, or microvascular obstruction up to 3 days after primary percutaneous coronary intervention after primary percutaneous coronary intervention
次要结局
- Activation of NLRP3 in peripheral blood vein measured in counts(30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention)
- Concentration of ASC in peripheral blood vein in ng/ml(30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention)
- Concentration of caspase in peripheral blood vein in pg/ml(30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention)
- Concentration of troponin in peripheral blood vein in ng/L(30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention)
研究者
dr. Birry Karim, SpPD-KKV
dr. Birry Karim, SpPD-KKV
Indonesia University