NL-OMON50634已完成3 期
ow-dose colchicine for secondary prevention of cardiovascular disease - LoDoCo2 trial - LoDoCo2
WCN (Werkgroep Cardiologische centra Nederland)0 个研究点目标入组 5,522 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,522
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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, frailty or a predicted 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
研究者
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