Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

JRCT ID: jRCT2021210033

Registered date:07/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ASCVD, CKD and systemic inflammation
• Date of first enrollment: 01/09/2021
• Target sample size: 400
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Denmark,Japan,Germany,Japan,Greece,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Lithuania,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Russian Federation,Japan,Serbia,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Turkey,Japan,Ukraine,Japan,United Kingdom,Japan
• Study type: Interventional
• Intervention(s): Ziltivekimab (s.c.) 15 mg once-monthly added to standard of care

Outcome(s)

Primary Outcome

Time to first occurrence of 3-point MACE, a composite
endpoint consisting of:
-CV death
-non-fatal MI
-non-fatal stroke

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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).

Exclude criteria

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).

Related Information

• Primary Sponsor: Miyazaki Daisuke
• Secondary ID(s): NCT05021835