ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Ziltivekimab
DrugZiltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly.
Placebo
DrugPlacebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: ZiltivekimabExperimental treatment 1 intervention
Group B: Placebo ziltivekimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Measured in months.
Time frame
From randomisation (month 0) to end-of-study (up to 25 months)Secondary outcomes
1
Number of CV death, non-fatal MI, non-fatal stroke
Measured as count of events.
Time frame
From randomisation (month 0) to end-of-study (up to 25 months)2
Time to first occurrence of a composite MACE endpoint consisting of: All-cause mortality, Non-fatal MI, Non-fatal stroke
Measured in months.
Time frame
From randomisation (month 0) to end-of-study (up to 25 months)3
Number of all-cause mortality, non-fatal MI, non-fatal stroke
Measured as count of events.
Time frame
From randomisation (month 0) to end-of-study (up to 25 months)4
Time to first occurrence of non-fatal MI
Measured in months.
Time frame
From randomisation (month 0) to end-of-study (up to 25 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Novo Nordisk A/S
Lead sponsor
Duke Clinical Research Institute
Collaborator
Source ClinicalTrials.gov