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

NCT06118281
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
clinicaltrials.gov
Participants
10,000
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Lead sponsor
Novo Nordisk A/S
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Start date
2024-06-25
clinicaltrials.gov
Number of sites
970
clinicaltrials.gov

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. 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.
clinicaltrials.gov
Acronym
ARTEMIS
clinicaltrials.gov
Short title
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack
clinicaltrials.gov
Official title
ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction
clinicaltrials.gov

Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
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Completion date
2026-12-14
clinicaltrials.gov
First posted
2023-11-07
clinicaltrials.gov
Registry last updated
2026-04-14
clinicaltrials.gov
Primary completion date
2026-12-14
clinicaltrials.gov
Start date
2024-06-25
clinicaltrials.gov

Participants
10,000
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
10,000
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Protocol amendments
5
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Number of sites
970
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06118281
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06118281
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  1. Number of CV death, non-fatal MI, non-fatal stroke

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as count of events.

  2. Time to first occurrence of a composite MACE endpoint consisting of: All-cause mortality, Non-fatal MI, Non-fatal stroke

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  3. Number of all-cause mortality, non-fatal MI, non-fatal stroke

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as count of events.

  4. Time to first occurrence of non-fatal MI

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  5. Time to first occurrence of MI (fatal and non-fatal)

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  6. Time to first occurrence of non-fatal stroke

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  7. Time to first occurrence of stroke (fatal and non-fatal)

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  8. Time to first occurrence of a 3-component coronary MACE endpoint comprising:CV death, Non-fatal MI, Ischaemia-driven coronary revascularisation

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  9. 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

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  10. Number of CV death, non-fatal MI, non-fatal stroke, ischaemia-driven coronary revascularisation, or HF hospitalisation or urgent HF visit

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measired as count of events.

  11. Time to first occurrence of a 3-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit, Outpatient HF visit

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  12. Number of CV deaths, HF hospitalisation or urgent HF visits or outpatient HF visit

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in count of events.

  13. Time to first occurrence of a 2-component HF endpoint comprising: CV death, HF hospitalisation or urgent HF visit

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as months.

  14. Number of CV deaths, HF hospitalisation or urgent HF visits

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in count of events.

  15. Time to first occurrence of a 2-component expanded HF endpoint comprising: HF hospitalisation or urgent HF visit, Outpatient HF visit

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as months.

  16. Number of HF hospitalisation or urgent HF visit or outpatient HF visit

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as count of events.

  17. Number of outpatient HF visit

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in count of events.

  18. Time to occurrence of CV death

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as months.

  19. Time to occurrence of all-cause death

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as months.

  20. 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

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  21. 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

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as count of events.

  22. Number of ischaemia-driven coronary revascularisation

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as count of events.

  23. Time to first occurrence of ischaemia-driven coronary revascularisation or any non-coronary revascularisation

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured in months.

  24. Number of ischaemia-driven coronary revascularisation or any non-coronary revascularisation

    Timeframe: From randomisation (month 0) to end-of-study (up to 25 months)

    Measured as count of events.

  25. Number of cardiovascular hospitalisations

    Timeframe: From randomisation (month 0) to 1 month/ 30 days

    Measured as count of events.

And 3 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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).
Sources for eligibility
clinicaltrials.gov

  • Advanced Cardiovascular, LLCAlexander City, United StatesActive, not recruiting
  • Birmingham VA Medical CenterBirmingham, United StatesActive, not recruiting
  • Grandview Medical CenterBirmingham, United StatesActive, not recruiting
  • Eastern Shore Rsrch Inst, LLCFairhope, United StatesActive, not recruiting
  • Heart Center Rsrch_HunstvilleHuntsville, United StatesActive, not recruiting
  • Mobile Heart USA Health Cardiology ClinicMobile, United StatesCompleted
  • Mercy Gilbert Medical CenterGilbert, United StatesActive, not recruiting
  • Mayo Clinic ArizonaPhoenix, United StatesActive, not recruiting
  • Honor HealthScottsdale, United StatesCompleted
  • Arkansas Cardiology ClinicLittle Rock, United StatesActive, not recruiting
  • Central Arkansas Veteran's Healthcare SystemLittle Rock, United StatesNot yet recruiting
  • Valley Clinical TrialsCovina, United StatesActive, not recruiting
  • Valley Clinical TrialsCovina, United StatesNot yet recruiting
  • UCSD Medical CenterLa Jolla, United StatesCompleted
  • Loma Linda University Faculty Medical ClinicsLoma Linda, United StatesCompleted
  • VAGrtrLosAngelesHlthcareSystemLos Angeles, United StatesCompleted
  • University of Californ LA-UCLALos Angeles, United StatesActive, not recruiting
  • University Of California IrvineOrange, United StatesActive, not recruiting
  • Kaiser Permanente Viewridge Medical OfficesSan Diego, United StatesCompleted
  • San Diego Cardiac CenterSan Diego, United StatesActive, not recruiting
  • San Francisco V.A. Medical CenterSan Francisco, United StatesCompleted
  • San Francisco V.A. Medical CenterSan Francisco, United StatesNot yet recruiting
  • LA BioMed Harbor UCLA Med CenrTorrance, United StatesCompleted
  • Torrance Memorial Medical CenterTorrance, United StatesCompleted
  • Interventional Cardiology Medical GroupWest Hills, United StatesActive, not recruiting

And 945 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506876-28
  • U1111-1294-3473
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)