NL-OMON54148招募中3 期
Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation - ZEUS
ovo Nordisk0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Chronic kidney disease defined by one of the below:
- •eGFR >=15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology
- •Collaboration (CKD-EPI) creatinine equation) or UACR >200 mg/g and eGFR>60
- •mL/min/1.73 m2 (using the CKD-EPI creatinine equation).
- •Serum hs-CRP *2 mg/L
- •Evidence of ASCVD by one or more of the following:
- •a) Coronary heart disease defined as at least one of the following:
- •i. Documented history of MI
- •ii. Prior coronary revascularisation procedure
- •iii. >=50% stenosis in major epicardial coronary artery documented by cardiac
- •catheterisation or CT coronary angiography
- •b) Cerebrovascular disease defined as at least one of the following:
- •i. Prior stroke of atherosclerotic origin
- •ii. Prior carotid artery revascularisation procedure
- •iii. >=50% stenosis in carotid artery documented by X-ray angiography, MR
- •angiography, CT angiography or Doppler ultrasound.
- •c) Symptomatic peripheral artery disease (PAD) defined as at least one of the
- •i. Intermittent claudication with an ankle-brachial index (ABI) <= 0.90 at rest
- •ii. Intermittent claudication with a >=50% stenosis in peripheral artery
- •(excluding carotid) documented by X-ray angiography, MR angiography, CT
- •angiography or Doppler ultrasound
- •iii. Prior peripheral artery (excluding carotid) revascularisation procedure
- •iv. Lower extremity amputation at or above ankle due to atherosclerotic disease
- •(excluding e.g. trauma or osteomyelitis).
排除标准
- •Clinical evidence of, or suspicion of, active infection at the discretion of
- •the investigator.
- •Myocardial infarction, stroke, hospitalisation for unstable angina pectoris,
- •or transient ischaemic attack within 60 days prior to randomisation (visit 2).
- •Planned coronary, carotid or peripheral artery revascularisation known on the
- •day of randomisation
- •Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure
- •(thoracoscopic or laparoscopic) within the past 60 days prior to randomisation
- •(visit 2) or any major surgical procedure planned at the time of randomisation
- •(visit 2).
研究者
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