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Recruiting Phase 3 NCT06118281

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

Phase 3 – large-scale trial before approval
Conditions: Cardiovascular Risk Acute Myocardial Infarction (AMI)

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
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.
Who can participate
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).
Locations 23
Argentina (1)
Instituto Cardiovascular Buenos Aires
CABA , Buenos Aires
ACTIVE_NOT_RECRUITING
Australia (1)
Concord Repatriation General Hospital - Cardiology Department
Concord , New South Wales
ACTIVE_NOT_RECRUITING
Brazil (1)
Hospital do Coração do Brasil
Brasília , Federal District
ACTIVE_NOT_RECRUITING
Bulgaria (1)
MHAT Puls AD, Cardiology Department
Blagoevgrad
ACTIVE_NOT_RECRUITING
Canada (1)
Heritage Medical Research Clinic
Calgary , Alberta
ACTIVE_NOT_RECRUITING
China (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
Czech Republic (1)
Krajská nemocice Liberec, a.s
Liberec , Czech Republic
ACTIVE_NOT_RECRUITING
Denmark (1)
Herlev og Gentofte Hospital
Hellerup , Capital Region
COMPLETED
France (1)
Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz
Besançon
ACTIVE_NOT_RECRUITING
Greece (1)
Univ Gen Hospital Larisa, Cardiology Medicine Clinic
Larissa/Thessaly , Greece
ACTIVE_NOT_RECRUITING
India (1)
Lalitha PVS Institute of Medical Sciences
Guntur , Andhra Pradesh
ACTIVE_NOT_RECRUITING
Israel (1)
Shamir MC - Cardiology Department
Beer Yaakov
ACTIVE_NOT_RECRUITING
Italy (1)
Ss. Annunziata
Chieti , Abruzzo
COMPLETED
Japan (1)
Miyazaki Medical Association Hospital_Cardiology
Miyazaki , Miyazaki
ACTIVE_NOT_RECRUITING
Malaysia (1)
Hospital Sultanah Aminah
Johor Bahru , Johor
ACTIVE_NOT_RECRUITING
Mexico (1)
Hospital Cardiológica Aguascalientes
Aguascalientes , Aguascalientes
ACTIVE_NOT_RECRUITING
Netherlands (1)
Jeroen Bosch Zkh
's-Hertogenbosch
ACTIVE_NOT_RECRUITING
Poland (1)
Zespol Zakladow Opieki Zdrowotnej w Ostrowie Wielkopolskim
Ostrów Wielkopolski , Greater Poland Voivodeship
ACTIVE_NOT_RECRUITING
South Korea (1)
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si , Gyeonggi-do
ACTIVE_NOT_RECRUITING
Spain (1)
Hospital Germans Trias i Pujol
Badalona , Barcelona
ACTIVE_NOT_RECRUITING
Turkey (1)
Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi- Kardiyoloji
Ankara , Altindag
ACTIVE_NOT_RECRUITING
United Kingdom (1)
Royal Cornwall Hospital (Treliske)
Truro , Cornwall
ACTIVE_NOT_RECRUITING
United States (1)
Advanced Cardiovascular, LLC
Alexander City , Alabama
ACTIVE_NOT_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
25.06.2024
Completion date
14.12.2026
Registry ID
NCT06118281
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.