ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Overview

About this study

The purpose of this study is to is to demonstrate the efficacy and safety of ziltivekimab in reducing the risk of major adverse CV events when initiated as early as possible in adult patients with ST-elevation and non-ST-elevation myocardial infarction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

-Age 18 years or above at the time of signing the informed consent
-Hospitalisation for acute myocardial infarction with evidence of type 1 MI (myocardial infarction) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities
-ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation or during hospitalisation, b) Electrocardiogram (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 leads greater than or equal to 0.25 millivolt (mV) in men less than 40 years, greater than or equal to 0.2 mV in men greater than or equal to 40 years, or greater than or equal to 0.15 mV in women in leads V2-V3; and/or greater than or equal to 0.1 mV in all other leads OR - Non-ST-segment myocardial infarction (NSTEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation or during hospitalisation, b) 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): a) Any prior MI b) Prior coronary revascularisation, c) Diabetes mellitus treated with glucose-lowering agent(s), d) Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than equal to 15 and less than 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), e) Prior ischaemic stroke, f) Known carotid disease or peripheral artery disease in the lower extremities, g) Multivessel coronary artery disease (current/prior), h) For STEMI participants only: anterior MI at index AMI

Exclusion Criteria

-Use of fibrinolytic therapy for treatment of the current AMI (acute myocardial infarction)
-Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV
-Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV, b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg))
-Severe kidney impairment defined as any of the following: Chronic haemodialysis or peritoneal dialysis
-Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN)
-Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation), b) Previously known or current ascites (clinical evaluation), c) Jaundice (clinical evaluation), d) Previous oesophageal/gastric variceal bleeding, e) Known hepatic cirrhosis
-Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery [CABG]), non-cardiac surgical, or major endoscopic procedure (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
-Known (acute or chronic) hepatitis B or hepatitis C
-History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) 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, b) 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)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/28/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Shahyar Gharacholou, M.D., M.S.

Contact us for the latest status

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

F Fortuin, M.D.

Contact us for the latest status

Contact information:

Alexandra Gaughan R.N.

(480) 574-1547

Gaughan.Alexandra@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20576279

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