EUCTR2020-004853-59-LTActive, not recruitingPhase 1
ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation - ZEUS
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 6,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Chronic kidney disease defined by one of the below:
- •- eGFR greater than or equal to 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
- •- UACR above or equal to 200 mg/g and eGFR above or equal to 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation).
- •- Serum hs-CRP greater than or equal to 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.greater than or equal to 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.greater than or equal to 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) below or equal to 0.90 at rest
- •ii.Intermittent claudication with a greater than or equal to 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).
- •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 1250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4950
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 randomisation (visit 2).
- •- 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).
Investigators
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