Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- AUC CRP
研究概览
简要总结
Background:
Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.
More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor outcomes or longer stay at hospital.
Endpoints:
-
Main endpoint: AUC CRP during the initial hospital stay
-
Secondary endpoints:
-
Clinical: oucomes
-
Imaging: ETT, MRI
-
Biological: various biomarkers
Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial inflarction (occlusion of coronary artery as assessed on the coronaro angiogram)
- •Adult (18-90y)
- •Men / women
- •Aigned informed consent
- •Health insurance
排除标准
- •Cardiogenic shock
- •Digestive troubles
- •Active bowels inflammatory disease (Crhon, chronic, diarrhea...)
- •Intolerance to the drug
- •Renal insufficiency clearance < 30mL/min
- •Immunosuppression, aplasia
- •Active infectious disease, active known neoplasia, chronic inflammatory disease
- •Hypersensitivity, allergy to one of studies components
- •Active liver disease
- •Poor hemodynamic conditions
- •Recent severe sepsis
- •Chronic treatment with corticoids or no steroids antiinflammatory agents
- •No possibility for informed consent
- •Protected by the law
- •Poor abservance
- •History of toxicomania, suicice attempts
- •Pregnacy, breeding, project of pregnancy
研究组 & 干预措施
Conventionnal treatment
Optimal conventional treatment used for patients admitted for STEMI (ESC guidelines 2012):
- Double anti-aggregation
- IEC (or sartan) at best tolerated dose
- Beta-blocker at best tolerated dose
- High dose statin (usually atorvastatin 80 mg daily)
- If ventricular dysfunction; inhibitor minérolcorticoïdes (the eplerenone more often)
- Any other treatment will be logged.
干预措施: Conventional treatment (Drug)
Conventionnal + Colchimax®
Optimal conventional treatment + Colchimax®
干预措施: Colchimax® (Drug)
Conventionnal + Colchimax®
Optimal conventional treatment + Colchimax®
干预措施: Conventional treatment (Drug)
结局指标
主要结局
AUC CRP
时间窗: 5 days
次要结局
- CPK measurement(1 year)
- Drug tolerance(1 year)
- CRP measurement(1 year)
- hospitalization time(1 year)
- measurement of left ventricular diastolic volume(Day of inclusion and one month after inclusion)
- measurement of left ventricular end-systolic volume(Day of inclusion and one month after inclusion)
- measurement remodeling(One month after inclusion)
- Troponin-hs measurement(1 year)
- Creatinine level(Day of inclusion and one month after inclusion)