Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Index of Microcirculatory resistance (IMR) between pre and post-coronary angioplasty.
研究概览
简要总结
This randomized clinical trial will determine the treatment effect of colchicine (1.5 mg loading dose and 0.5 mg daily thereafter) for 6 weeks on microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.
详细描述
Despite significant advances in the treatment of coronary artery disease, acute coronary syndromes (ACS) remain one of the leading causes of mortality and morbidity worldwide. In Chile, it is estimated that cardiovascular disease is responsible for one out of every four deaths Moreover, the consequences of an infarction, i.e., myocardial damage and death, lead to disability, loss of productivity, and economic costs.
Based on the knowledge that ACS occurs as a consequence of the atheroma plaque complication (rupture or erosion) and the consequent thrombosis at that level, current therapy in patients admitted for ACS includes :
(i) acute inhibition of thrombosis by means of antiplatelet and anticoagulant drugs.
ii) Coronary revascularization for severe stenosis by means of coronary angioplasty or bypass surgery.
These therapies have resulted in marked patient benefit, however, in many cases fail to reduce myocardial damage and to achieve adequate myocardial reperfusion.
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
- None
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.
- •Adults hospitalized at the Clinical Hospital of the Catholic University for an ACS condition, defined as:
- •Presence of chest pain, associated with enzymatic elevation (increase of ultrasensitive troponin above normal value (99th percentile)) with or without electrocardiographic changes.
- •Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization).
- •Ability and willingness to provide written informed consent.
排除标准
- •ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of colchicine).
- •Severe left main stenosis.
- •Advanced heart failure, left ventricular ejection fraction <35%.
- •Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease).
- •Severe liver disease (transaminase elevation 3 times above normal), blood dyscrasia (leukocyte or platelet count lower than normal), glomerular filtration rate (MDRD), use of CYP3A4 or calcineurin inhibitors, active autoimmune disease or the use of chronic anti-inflammatory therapy, concomitant infection, pregnancy or concomitant infection, pregnancy or lactation.
- •Any other disease that limits life expectancy to <1 year.
- •Medical history of a disorder that could, in the opinion of the treating physician, place the participant at significant risk if they were to participate in the trial.
研究组 & 干预措施
Colchicine
Subjects allocated to the intervention group will receive colchicine + standard of care for 6 weeks.
干预措施: Colchicine (Drug)
结局指标
主要结局
Change in Index of Microcirculatory resistance (IMR) between pre and post-coronary angioplasty.
时间窗: baseline ( pre-angioplasty) and at the end of the procedure (angioplasty)
Invasive assessment of Index of Microvascular Resistance (IMR) before and after angioplasty in both colchicine and control group.
次要结局
- Change in level of inflammatory markers ( Ultra-sensible C-reactive protein and IL-6) at baseline and 6 week follow-up.(baseline (prior to Colchicine administration) and at 6 weeks after discharge)
- Percent of salvaged myocardium.(baseline (two - four days post-angioplasty and at 6 weeks after discharge)
- Change in cardiac enzyme levels (troponin) before and after angioplasty in both colchicine and control group.(baseline (pre-angioplasty) and 24 h post-angioplasty)
- Average value of endpoint IMR.(at the end of the procedure (angioplasty))