ow-dose colchicine for secondary prevention of cardiovascular disease - LoDoCo2

Werkgroep Cardiologische centra Nederland0 个研究点目标入组 5,447 人开始时间: 2016年4月25日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•1. Age >35 and <82 years
•2. Proven coronary artery disease; as evidenced by coronary angiography, CT coronary angiography or a Coronary Artery Calcium Score (Agatston score >400). Individuals with a history of bypass surgery are only eligible if they have undergone coronary artery bypass surgery more than 10 years before, or have angiographic evidence of graft failure or have undergone percutaneous intervention since their bypass surgery
•3. Clinically stable for at least six months
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4023
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2030

•1. Women who are pregnant, breast feeding or may be considering pregnancy during the study period
•2. Renal impairment as evidenced by a serum creatinine >150 µmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2
•3. Severe heart failure – systolic or diastolic New York Heart Association Functional classification 3 or 4
•4. Moderate or severe valvular heart disease considered likely to require intervention
•5. Dependency or frailty or an estimated life expectancy < 5 years
•6. Peripheral neuritis, myositis or marked myo-sensitivity to statins
•7. Requirement for long term colchicine therapy for any other reason
•8. Current enrollment in another trial.

发起方

Werkgroep Cardiologische centra Nederland