Last updated 42 days ago
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack
10000 patients around the world
Available in Spain, Argentina
Novo Nordisk A/S
10000Patients around the world
This study is for people with
Coronary heart disease
Acute myocardial infarction
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Age 18 years or above at the time of signing the informed consentHospitalisation for acute myocardial infarction with evidence of type 1 MI (myocardial infarction) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilitiesST-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 limitPossibility 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 NSTEMIPresence 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
- 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 IVOngoing 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 dialysisKnown 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 cirrhosisMajor 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 allowedClinical evidence of, or suspicion of, active infection at the discretion of the investigatorKnown (acute or chronic) hepatitis B or hepatitis CHistory 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)
StudyARTEMIS
SponsorNovo Nordisk A/S
Conditions
Acute myocardial infarction
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06118281
