Recruiting NCT06118281

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

Phase III Interventional Cardiovascular Risk Acute Myocardial Infarction (AMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Ziltivekimab, Placebo.
Who it may be relevant to: Registry conditions: Cardiovascular Risk, Acute Myocardial Infarction (AMI). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Bulgaria +19
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction

Overview

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Interventions

Drug Ziltivekimab
Ziltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly.
Drug Placebo
Placebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.

Primary outcome measures

Time to first occurrence of a 3-component major adverse cardiovascular event (MACE) endpoint comprising: Cardiovascular (CV) death, Non-fatal myocardial infarction (MI), Non-fatal stroke [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]

Secondary outcome measures (12)

Number of CV death, non-fatal MI, non-fatal stroke [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of a composite MACE endpoint consisting of: All-cause mortality, Non-fatal MI, Non-fatal stroke [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Number of all-cause mortality, non-fatal MI, non-fatal stroke [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of non-fatal MI [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of MI (fatal and non-fatal) [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of non-fatal stroke [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of stroke (fatal and non-fatal) [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of a 3-component coronary MACE endpoint comprising:CV death, Non-fatal MI, Ischaemia-driven coronary revascularisation [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of a 5-component expanded MACE endpoint comprising: CV death, Non-fatal MI, Non-fatal stroke, Ischaemia-driven coronary revascularisation, Heart failure (HF) hospitalisation or urgent HF visit [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Number of CV death, non-fatal MI, non-fatal stroke, ischaemia-driven coronary revascularisation, or HF hospitalisation or urgent HF visit [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Time to first occurrence of a 3-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit, Outpatient HF visit [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]
Number of CV deaths, HF hospitalisation or urgent HF visits or outpatient HF visit [Time frame: From randomisation (month 0) to end-of-study (up to 25 months)]

Eligibility criteria

Key inclusion:

Age 18 years or above at the time of signing the informed consent.
Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities.
ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation, at the investigator's discretion.

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 0.25 (millivolt) mV in men less than 40 years, greater than or equal 0.2 mV in men greater than or equal 40 years, or greater than or equal 0.15 mV in women in leads V2-V3; and/or greater than or equal 0.1 mV in all other leads.

Non-ST-segment myocardial infarction with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation, at the investigator's discretion. b) Rise and/or fall in car-diac troponin I or T with at least one value above the 99th percentile upper reference limit.
Possibility for both randomisation and administration of the loading dose of study intervention as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 72 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 ongoing glucose-lowering agent(s). d)Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than or 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 patients only: anterior MI at index acute myocardial infarction (AMI)

Key exclusion:

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: 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: a) eGFR less than 15 mililitre per minute per 1.73 m\^2. b) 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 eval-uation). c) Jaundice (clinical evaluation). d) Previous oesophageal/gastric variceal bleeding. c) 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment