Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation(EX6018-4758) (ZEUS)

Novo Nordisk Pharma Ltd.0 个研究点目标入组 400 人开始时间: 2021年9月1日最近更新: 2024年3月28日

试验速览

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•Key inclusion criteria:
•eGFR>=15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
•Serum hs-CRP >=2 mg/L at screening (visit 1)
•Evidence of ASCVD by one or more of the following within the last 5 years from screening:
•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 following:
•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).

•Key exclusion criteria:
•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 screening (visit 1).
•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).

Time to first occurrence of 3-point MACE

A composite endpoint consisting of: - CV death - non-fatal MI - non-fatal stroke

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