Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06118281




Registration number
NCT06118281
Ethics application status
Date submitted
31/10/2023
Date registered
7/11/2023
Date last updated
2/04/2024

Titles & IDs
Public title
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack
Scientific title
ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction
Secondary ID [1] 0 0
U1111-1294-3473
Secondary ID [2] 0 0
EX6018-4979
Universal Trial Number (UTN)
Trial acronym
ARTEMIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Risk 0 0
Acute Myocardial Infarction (AMI) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ziltivekimab
Treatment: Drugs - Placebo

Experimental: Ziltivekimab - Participants will receive an initial loading dose of ziltivekimab Dose 1 subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for ST-elevation myocardial infarction (STEMI) and within 48 hours of hospitalisation for non-ST-elevation myocardial infarction (NSTEMI), followed by ziltivekimab Dose 2 s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care.

Experimental: Placebo ziltivekimab - Participants will receive placebo matched to ziltivekimab at an initial loading dose subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for STEMI and latest within 48 hours of hospitalisation for NSTEMI, followed by placebo matched to ziltivekimab s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care.


Treatment: Drugs: Ziltivekimab
Ziltivekimab will be adminsitered subcutaneously as an initial loading dose of Dose 1 followed by a maintenance dose of Dose 2 once- monthly.

Treatment: Drugs: Placebo
Placebo matched to ziltivekimab will be adminsitered subcutaneously as an initial loading dose followed by a maintenance dose once-monthly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [1] 0 0
Number of CV death, non-fatal MI, non-fatal stroke
Timepoint [1] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [2] 0 0
Time to first occurrence of a composite MACE endpoint consisting of: All-cause mortality, Non-fatal MI, Non-fatal stroke
Timepoint [2] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [3] 0 0
Number of all-cause mortality, non-fatal MI, non-fatal stroke
Timepoint [3] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [4] 0 0
Time to first occurrence of non-fatal MI
Timepoint [4] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [5] 0 0
Time to first occurrence of MI (fatal and non-fatal)
Timepoint [5] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [6] 0 0
Time to first occurrence of non-fatal stroke
Timepoint [6] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [7] 0 0
Time to first occurrence of stroke (fatal and non-fatal)
Timepoint [7] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [8] 0 0
Time to first occurrence of a 3-component coronary MACE endpoint comprising:CV death, Non-fatal MI, Ischaemia-driven coronary revascularisation
Timepoint [8] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [10] 0 0
Number of CV death, non-fatal MI, non-fatal stroke, ischaemia-driven coronary revascularisation, or HF hospitalisation or urgent HF visit
Timepoint [10] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [11] 0 0
Time to first occurrence of a 3-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit, Outpatient HF visit
Timepoint [11] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [12] 0 0
Number of CV deaths, HF hospitalisation or urgent HF visits or outpatient HF visit
Timepoint [12] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [13] 0 0
Time to first occurrence of a 2-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit
Timepoint [13] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [14] 0 0
Number of CV deaths, HF hospitalisation or urgent HF visits
Timepoint [14] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [15] 0 0
Time to first occurrence of a 2-component expanded HF endpoint comprising: HF hospitalisation or urgent HF visit, Outpatient HF visit
Timepoint [15] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [16] 0 0
Number of HF hospitalisation or urgent HF visit or outpatient HF visit
Timepoint [16] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [17] 0 0
Number of outpatient HF visit
Timepoint [17] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [18] 0 0
Time to occurrence of CV death
Timepoint [18] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [19] 0 0
Time to occurrence of all-cause death
Timepoint [19] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [20] 0 0
Time to first occurrence of 6-component vascular event endpoint: CV death, Non-fatal MI, Non-fatal stroke, Ischaemia-driven coronary revascularisation, Non-coronary revascularisation procedure, Any other non-coronary ischaemic event excluding stroke
Timepoint [20] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [21] 0 0
Number of CV death, non-fatal MI and non-fatal stroke, ischaemia-driven coronary revascularisation, non-coronary revascularisation procedure, or any other non-coronary ischaemic event excluding stroke
Timepoint [21] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [22] 0 0
Number of ischaemia-driven coronary revascularisation
Timepoint [22] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [23] 0 0
Time to first occurrence of ischaemia-driven coronary revascularisation or any non-coronary revascularisation
Timepoint [23] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [24] 0 0
Number of ischaemia-driven coronary revascularisation or any non-coronary revascularisation
Timepoint [24] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [25] 0 0
Number of cardiovascular hospitalisations
Timepoint [25] 0 0
From randomisation (month 0) to 1 month/ 30 days
Secondary outcome [26] 0 0
Number of cardiovascular hospitalisations
Timepoint [26] 0 0
From randomisation (month 0) to 12 months
Secondary outcome [27] 0 0
Number of hospitalisations with infection as primary cause or death due to infection
Timepoint [27] 0 0
From randomisation (month 0) to end-of-study (up to 25 months)
Secondary outcome [28] 0 0
Change in high-sensitivity C-reactive protein (hs-CRP)
Timepoint [28] 0 0
From randomisation (month 0) to 6 months

Eligibility
Key inclusion criteria
- Age 18 years or above at the time of signing the informed consent

- Hospitalisation for acute myocardial infarction with evidence of type 1 MI (myocardial
infarction) by invasive angiography performed at site with percutaneous coronary
intervention (PCI) capabilities

- ST-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 limit

- Possibility 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 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 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
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: 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 evaluation), c) Jaundice (clinical evaluation), d) Previous
oesophageal/gastric variceal bleeding, e) 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
25/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/09/2026
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Cardiology - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Illawarra Heart Health Centre - Wollongong
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [5] 0 0
Cairns Base Hospital - Cairns
Recruitment hospital [6] 0 0
Gold Coast University Hosptial - Southport
Recruitment hospital [7] 0 0
Royal Adelaide Hospital Cardiovascular Clinical Trials - Adelaide
Recruitment hospital [8] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [9] 0 0
Northern Health - Epping
Recruitment hospital [10] 0 0
Frankston Hospital - Frankston
Recruitment hospital [11] 0 0
Barwon Health (The Geelong Hospital) - Geelong
Recruitment hospital [12] 0 0
Austin Health - Heidelberg
Recruitment hospital [13] 0 0
The Alfred Hospital - South Yarra
Recruitment hospital [14] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
3076 - Epping
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3004 - South Yarra
Recruitment postcode(s) [14] 0 0
3021 - St Albans
Recruitment postcode(s) [15] 0 0
6000 - Perth
Recruitment outside Australia
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Alabama
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Burgas
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China
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Hangzhou
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China
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Harbin
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China
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Nanjing
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China
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Shanghai
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China
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Xi'an
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Czech Republic
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Czechia
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Brno
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Pardubice
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Prague
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Czechia
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Praha 10
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Czechia
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Czechia
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Praha
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Czechia
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Ústní Nad Labem
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Region Hovedstaden
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Aalborg
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Aarhus N
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Copenhagen
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Hillerød
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Odense C
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Svendborg
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Besançon Cedex
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France
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Caen Cedex 9
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Chambray Les Tours
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Corbeil Essonnes
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France
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Grenoble cedex 9
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France
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Le Coudray
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France
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Lille
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France
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Lyon
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Paris
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Pessac
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Toulouse Cedex 9
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Vandoeuvre Les Nancy
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Germany
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Bad Berka
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Berlin
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Bielefeld
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Bremen
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Germany
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Duke Clinical Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06118281
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency dept. 2834
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06118281