In patients who present with acute coronary syndromes, does addition of low-dose colchicine to standard medical therapy, compared to standard medical therapy alone, reduce the major adverse cardiovascular events at 12 months?

St. Vincent's Hospital Melbourne0 个研究点目标入组 800 人开始时间: 2015年8月18日最近更新: 2020年11月16日

适应症

试验速览

暂无简介。

•Age between 18 to 85 years old
•- Patients who are admitted to the hospital with acute coronary syndromes (also known as a heart attack) - defined by elevated troponin with ischaemic symptoms or ECG changes
•- Presence of coronary artery disease on coronary angiogram – defined by >30% luminal stenosis in epicardial vessel of >2.5mm luminal diameter, which is managed with PCI or medical therapy
•- Able to provide written informed consent

•- Coronary artery disease requiring surgical revascularization
•- Pre-existing long-term colchicine use for other medical conditions
•- Pre-existing, or plan for, administration of other immunosuppressant therapy
•- Severe liver impairment – defined by elevated serum ALT and/or AST levels twice the upper limit of normal AND total serum bilirubin level twice the upper limit of normal OR coagulopathy (INR>1.5)
•- Severe renal insufficiency – defined by eGFR<30mL/min/1.73m2
•- Pre-existing use of strong CYP3A4 or P-glycoprotein inhibitors (eg. cyclosporine, antiretroviral drugs, antifungals, erythromycin and clarithromycin) and no other alternative medical therapy can be used
•- Known active malignancy
•- Known allergy or hypersensitivity to colchicine
•- Pregnant and lactating woman or woman with childbearing potential without effective birth control methods

发起方

St. Vincent's Hospital Melbourne