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

Acute Myocardial Infarction (AMI) | Cardiovascular Risk

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation 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.

OR

* 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).

Study Location

Grey Nuns Community Hospital
Grey Nuns Community Hospital
Edmonton, Alberta
Canada

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Saint Paul's Hospital
Saint Paul's Hospital
Vancouver, British Columbia
Canada

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Royal Victoria Regional Health Centre
Royal Victoria Regional Health Centre
Barrie, Ontario
Canada

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Royal Alexandra Hospital
Royal Alexandra Hospital
Edmonton, Alberta
Canada

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London Health Sciences Center Ontario
London Health Sciences Center Ontario
London, Ontario
Canada

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Vancouver General Hospital
Vancouver General Hospital
Vancouver, British Columbia
Canada

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Health Sciences North Rsrch Inst
Health Sciences North Rsrch Inst
Sudbury, Ontario
Canada

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CIUSS Hopit de Chicoutimi
CIUSS Hopit de Chicoutimi
Chicoutimi, Quebec
Canada

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QE II Health Sciences Centre
QE II Health Sciences Centre
Halifax, Nova Scotia
Canada

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CISSSL Hôsp Pierre-Le Gardeur
CISSSL Hôsp Pierre-Le Gardeur
Terrebonne, Quebec
Canada

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Kingston General Hospital
Kingston General Hospital
Kingston, Ontario
Canada

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Niagara Health System
Niagara Health System
St. Catharines, Ontario
Canada

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UHN-Toronto General Hospital
UHN-Toronto General Hospital
Toronto, Ontario
Canada

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CISSS de Lanaudière - Centre hospitalier De Lanaudière
CISSS de Lanaudière - Centre hospitalier De Lanaudière
Saint-Charles-Borromée, Quebec
Canada

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Royal University Hospital
Royal University Hospital
Saskatoon, Saskatchewan
Canada

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Heritage Medical Research Clinic
Heritage Medical Research Clinic
Calgary, Alberta
Canada

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Kelowna Cardiology Res. Ltd.
Kelowna Cardiology Res. Ltd.
Kelowna, British Columbia
Canada

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New Brunswick Heart Centre
New Brunswick Heart Centre
Saint John, New Brunswick
Canada

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Hamilton Health Sciences Corp, Ontario
Hamilton Health Sciences Corp, Ontario
Hamilton, Ontario
Canada

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University of Ottawa Heart Ins
University of Ottawa Heart Ins
Ottawa, Ontario
Canada

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St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

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Hopital Sacre-Coeur de Montreal
Hopital Sacre-Coeur de Montreal
Montréal, Quebec
Canada

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Regina General Hospital
Regina General Hospital
Regina, Saskatchewan
Canada

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University of Alberta Hospital_Edmonton
University of Alberta Hospital_Edmonton
Edmonton, Alberta
Canada

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St. Boniface Hospital
St. Boniface Hospital
Winnipeg, Manitoba
Canada

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William Osler Hel Bra Civic Hs
William Osler Hel Bra Civic Hs
Brampton, Ontario
Canada

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Southlake Regional Hlth Centre
Southlake Regional Hlth Centre
Newmarket, Ontario
Canada

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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

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CHUM Centre de Recherch Hotel-Dieu
CHUM Centre de Recherch Hotel-Dieu
Montreal, Quebec
Canada

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Centre hosp affilié univ rég
Centre hosp affilié univ rég
Trois-Rivières, Quebec
Canada

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Health Sciences North Rsrch Inst
Health Sciences North Rsrch Inst
Greater Sudbury, Ontario
Canada

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Univ of Alberta Hosp Edmonton
Univ of Alberta Hosp Edmonton
Edmonton, Alberta
Canada

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Hopital Sacre-Coeur de Montreal
Hopital Sacre-Coeur de Montreal
Montreal, Quebec
Canada

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CISSS de Lanaudiere - Centre hospitalier De Lanaudiere
CISSS de Lanaudiere - Centre hospitalier De Lanaudiere
Saint-Charles-Borromée, Quebec
Canada

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Study Sponsored By
Novo Nordisk A/S
Participants Required
More Information
Study ID: NCT06118281