Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction

JRCT ID: jRCT2061240014

Registered date:17/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: acute myocardial infarction
• Date of first enrollment: 25/06/2024
• Target sample size: 275
• Countries of recruitment: Australia,Japan,Denmark,Japan,Turkiye,Japan,Bulgaria,Japan,Greece,Japan,Argentina,Japan,Brazil,Japan,Spain,Japan,South Korea,Japan,China,Japan,Poland,Japan,America,Japan,Czech,Japan,Italy,Japan,Canada,Japan,Mexico,Japan,England,Japan,Germany,Japan,France,Japan,Netherlands,Japan,India,Japan,Malaysia,Japan,Israel,Japan
• Study type: Interventional
• Intervention(s): Loading dose of ziltivekimab 30 mg s.c. followed by ziltivekimab 15 mg s.c. once-monthly, both 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: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Hospitalisationa for acute myocardial infarction with evidence of type 1 MI by invasive angiography performed at site with PCI capabilities.
-ST-segment elevation myocardial infarction with all the following:
1.Relevant symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation or during hospitalisation.
2.ECG-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous lead >=0.25 mV in men <40 years, >=0.2 mV in men >=40 years, or >=0.15 mV in women in leads V2-V3: and/or >=0.1 mV in all other leads. or
-Non-ST-segment myocardial infarction with all the following:
1.Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation or during hospitalisation.
2.Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.
-Possibility for randomisation as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 48 hours of hospitalisation (time 0) for NSTEMI.
-Presence of at least one of the following criteria (confirmed based on the participants medical records and/or medical history interview):
1.Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation or during hospitalisation.
2.Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.
-Possibility for randomisation as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 48 hours of hospitalisation (time 0) for NSTEMI.
-Presence of at least one of the following criteria (confirmed based on the participant's medical records and/or medical history interview):
-Any prior MI.
-Prior coronary revascularisation.c
-Diabetes mellitus treated with glucose-lowering agent(s).
-Known CKD (eGFR >=15 and <60 mL/min/1.73 m2).
-Prior ischaemic stroke.
-Known carotid disease or peripheral artery disease in the lower extremities.
-Multivessel coronary artery diseased (current/prior).
-For STEMI patients only: anterior MI at index AMI.

Exclude criteria

-Use of fibrinolytic therapy for treatment of the current AMI.
-Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV.
-Ongoing haemodynamic instability defined as any of the following:
-Killip Class III or IV.
-Sustained and/or symptomatic hypotension (systolic blood pressure <90 mmHg).
-Severe kidney impairment defined as any of the following:
-eGFR <15 mL/min/1.73 m2.
-Chronic haemodialysis or peritoneal dialysis.
-Known ALT >8 x ULN
-Severe hepatic disease defined as at least one of the following:
-Previously known or current hepatic encephalopathy (clinical evaluation).
-Previously known or current ascites (clinical evaluation).
-Jaundice (clinical evaluation).
-Previous oesophageal/gastric variceal bleeding.
-Known hepatic cirrhosis.
-Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery [CABG]), non-cardiac surgical, or major endoscopic procedureb (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG). Deferred (staged) percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed.
-Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.c
-Known (acute or chronic) hepatitis B or hepatitis C.
-History or evidence of untreated latent tuberculosis (TB) such as (but not limited to):
-History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation.
-Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2).

Related Information

• Primary Sponsor: Okada Takumi
• Secondary ID(s): NCT06118281