NCT01936285Unknown4 期
Study of Anti-inflammatory Treatment With Colchicine in the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size
G.Gennimatas General Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Infarct size on MRI
研究概览
简要总结
- There is evidence that inflammatory processes may play detrimental role during the acute phase of myocardial infarction
- The hypothesis of this study is that colchicine, by its anti-inflammatory action, may lead to reduction in infarct size, when administered during the acute phase of myocardial infarction
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)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will enroll patients 18 years old or older who present to the hospital within twelve (12) hours of the onset of chest pain and who had ST segment elevation >1 mm in two contiguous limb leads or ST segment elevation >2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.
- •Excluded patients:
- •> 80 years old
- •with active inflammatory diseases, infectious diseases or known malignancy
- •under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
- •with known hypersensitivity-allergy to colchicine
- •under chronic treatment with colchicine
- •with severe renal failure (eGFR < 30 ml/min/1.73 m2)
- •with hepatic failure (Child - Pugh class B or C)
- •presenting with cardiac arrest
- •presenting with ventricular fibrillation
- •presenting with cardiogenic shock
- •with stent thrombosis
- •with angina within 48 hours before infarction
- •with previous myocardial infarction
- •with occlusion of the left main or left circumflex coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
- •with metallic implants (ferromagnetic material)
排除标准
- 未提供
研究组 & 干预措施
Control group
Placebo Comparator
Patients taking placebo
干预措施: Placebo (Drug)
Colchicine
Experimental
Active treatment group
干预措施: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days (Drug)
结局指标
主要结局
Infarct size on MRI
时间窗: 5 days post-MI
MRI with LGE will be performed in a subset of study participants
AUC CK-MB concentration
时间窗: 0-3 days post-MI
Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits
次要结局
- Myocardial damage marker levels(Days 1-3 post-MI)
研究者
Spyridon Deftereos
Director, Cardiac Catheterization Department
G.Gennimatas General Hospital
研究点 (1)
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