A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation (ZEUS)

In by alicia.green

Locations
Jacksonville (Headquarters)
Condition
Heart Disease, Kidney Disease

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation (ZEUS)

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Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Estimated glomerular filtration rate (eGFR) 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
  2. Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L at screening (visit 1)
  3. Evidence of atherosclerotic cardiovascular disease (ASCVD) by one or more of the following:
    • a) Coronary heart disease defined as at least one of the following:
      • Documented history of MI
      • Prior coronary revascularisation procedure
      • Greater than or equal to 50% stenosis in major epicardial coronary artery documented by cardiac catheterization or CT coronary angiography
    • Cerebrovascular disease defined as at least one of the following:
      • Prior stroke of atherosclerotic origin
      • Prior carotid artery revascularisation procedure
      • Greater than or equal to 50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound.
    • Symptomatic peripheral artery disease (PAD) defined as at least one of the following:
      • Intermittent claudication with an ankle-brachial index (ABI) below or equal to 0.90 at rest
      • 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
      • Prior peripheral artery (excluding carotid) revascularisation procedure
      • Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).
Exclusion Criteria
  1. Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
  2. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2).
  3. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (visit 1).
  4. 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).
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