On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 3
- 主要终点
- hsCRP change between admission and discharge
研究概览
简要总结
Since colchicine is known to have anti-inflammatory effects and inflammation is an early component of acute coronary syndrome (ACS), this study aims to evaluate the acute effects of low-dose colchicine, in addition to atorvastatin, administered on-admission to statin-naive patients with non-ST elevation ACS scheduled for early invasive strategy.
详细描述
On-admission all statin naive NSTEACS patients are randomized to receive either standard treatment of atorvastatin 80 mg or standard treatment plus colchicine (1 mg loading dose followed by 0.5 mg/day).
Inflammatory biomarker high sensitivity C reactive protein (hs-CRP) is measured in all patients on-admission and every 24 hours thereafter until discharge.
Cardiac and renal function parameters are evaluated to evidence the possible beneficial effects of the administration of colchicine in addition to atorvastatin alone both short- and medium-term (up to 30 days).
Colchicine tolerance is also investigated through monitoring for clinical side effects.
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
- •non-ST elevation acute coronary syndrome;
- •≥ 18 years;
- •statin-naive.
排除标准
- •prior statin therapy and/or colchicine treatment;
- •known allergy or hypersensitivity to colchicine or statins;
- •current treatment with potent inhibitors of CYP3A4 or P-glycoprotein (eg., Cyclosporin, antiretroviral drugs, antimycotics, erythromicin and clarythromycin);
- •previous or scheduled administration of any immunosuppressive therapy;
- •known active malignancy;
- •severe kidney disease (creatinine > 3 mg/dl or dialysis)
- •severe liver disease (ALT and/or AST, > double ref. normal values in case of (a) total bilirubin > double ref. normal values, or (b) alteration in coagulation (INR> 1,5);
- •severe heart failure (NYHA class ≥ 3 or cardiogenic shock) at hospital presentation;
- •severe acute or chronic gastro-intestinal disease (nausea, vomiting, diarrhea, malabsorption disease, malnutrition);
- •pregnancy or lactation;
- •current COVID-19 or other infectious disease;
- •refusal of consent.
研究组 & 干预措施
Colchicine and Atorvastatin
Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge plus Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
干预措施: Colchicine (Drug)
Colchicine and Atorvastatin
Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge plus Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
干预措施: Atorvastatin (Drug)
Atorvastatin
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
hsCRP change between admission and discharge
时间窗: Average 4 days: from admission to discharge
Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone
次要结局
- Delta variation in creatinine value from baseline to peak(Creatinine value is measured daily during hospitalization - average 4 days)
- Acute kidney injury incidence(Creatinine value is measured daily during hospitalization - average 4 days)
- CK-MB peak value(CK-MB value is measured daily during hospitalization - average 4 days)
- Tolerance to colchicine(From admission to discharge - Approximately 4 days)
- Glomerular filtration rate changes at 30 days after discharge(Approximately 30 days)
- Adverse clinical events from admission to 30 days after discharge(Approximately 30 days)
研究者
Anna Toso
Cardiologist at the Santo Stefano Hospital, Prato, Italy
Azienda USL Toscana Centro