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ARTEMIS - A research study to look at how ziltivekimab works compared to placebo in people who have had a heart attack
EU CTIS ID: 2023-506876-28-00
What this study is testing
To demonstrate the superiority of a CCI of ziltivekimab CCI s.c. vs placebo followed by ziltivekimab CCI s.c. once monthly versus placebo, both added to standard of care, in reducing the risk of 4-component MACE in participants with AMI
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Hospitalisation (a) for acute myocardial infarction with evidence of type 1 MI (b) by invasive angiography performed at site with PCI capabilities (c).
- (h) Carotid artery disease defined as 1) ≥50% stenosis in carotid artery documented by angiography, MR angiography, CT angiography or Doppler ultrasound or 2) prior carotid artery revascularization procedure. Peripheral artery disease in lower extremities defined as 1) ≥50% stenosis in peripheral artery in lower extremities documented by angiography, MR angiography, CT angiography or Doppler ultrasound, 2) prior peripheral artery revascularization procedure or 3) lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis)
- (i) Defined as ≥50% stenosis on 2 or more epicardial artery territories or the left main artery during a prior cardiac catheterisation or cardiac catheterisation during the current AMI, or prior percutaneous coronary intervention (PCI) and ≥50% stenosis of at least 1 epicardial artery territory different from the prior revascularised artery, or prior multivessel coronary bypass grafting.
- ST-segment elevation myocardial infarction with all the following (d): Relevant onset of symptoms suggestive of cardiac ischaemia related to the index AMI, no longer than within 12 hours before hospitalisation, at the investigator's discretion. 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 ≥0.25 mV in men <40 years, ≥0.2 mV in men ≥40 years, or ≥0.15 mV in women in leads V2-V3; and/or ≥0.1 mV in all other leads.
- Or Non-ST-segment myocardial infarction with all the following: Relevant onset or worsening of symptoms suggestive of cardiac ischaemia related to the index AMI, no longer than within 24 hours before hospitalisation, at the investigator's discretion. Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.
- Possibility for both randomisation and administration of the CCI 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.
You likely can't join if
- Use of fibrinolytic therapy for treatment of the current AMI.
- Severe hepatic disease defined as at least one of the following: Previously known or current hepatic encephalopathy (clinical evaluation), Previously known or current ascites (clinical evaluation), Jaundice (clinical evaluation), Previous oesophageal/gastric variceal bleeding, Known hepatic cirrhosis
- Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery [CABG]), non-cardiac surgical, or major endoscopic procedure(b) (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 (c).
- Known (acute or chronic) hepatitis B or hepatitis C (c)
- History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): 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. Participants with TB risk factors (see details in Section 8.2.6)but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2)
See the full eligibility criteria
Who can join
- Hospitalisation (a) for acute myocardial infarction with evidence of type 1 MI (b) by invasive angiography performed at site with PCI capabilities (c).
- (h) Carotid artery disease defined as 1) ≥50% stenosis in carotid artery documented by angiography, MR angiography, CT angiography or Doppler ultrasound or 2) prior carotid artery revascularization procedure. Peripheral artery disease in lower extremities defined as 1) ≥50% stenosis in peripheral artery in lower extremities documented by angiography, MR angiography, CT angiography or Doppler ultrasound, 2) prior peripheral artery revascularization procedure or 3) lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis)
- (i) Defined as ≥50% stenosis on 2 or more epicardial artery territories or the left main artery during a prior cardiac catheterisation or cardiac catheterisation during the current AMI, or prior percutaneous coronary intervention (PCI) and ≥50% stenosis of at least 1 epicardial artery territory different from the prior revascularised artery, or prior multivessel coronary bypass grafting.
- ST-segment elevation myocardial infarction with all the following (d): Relevant onset of symptoms suggestive of cardiac ischaemia related to the index AMI, no longer than within 12 hours before hospitalisation, at the investigator's discretion. 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 ≥0.25 mV in men <40 years, ≥0.2 mV in men ≥40 years, or ≥0.15 mV in women in leads V2-V3; and/or ≥0.1 mV in all other leads.
- Or Non-ST-segment myocardial infarction with all the following: Relevant onset or worsening of symptoms suggestive of cardiac ischaemia related to the index AMI, no longer than within 24 hours before hospitalisation, at the investigator's discretion. Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.
- Possibility for both randomisation and administration of the CCI 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.
- Age 18 years or above at the time of signing the informed consent.
- Presence of at least one of the following criteria confirmed based on the participant’s medical records and/or medical history interview: Any prior MI (e), Prior coronary revascularisation (f), Diabetes mellitus treated with ongoing glucose-lowering agent(s) (e), Known CKD (eGFR ≥15 and <60 mL/min/1.73 m2) (g), Prior ischaemic stroke (e), Known carotid disease or peripheral artery disease in the lower extremities (h), Multivessel coronary artery disease (current/prior) (i).
- (a) Hospitalisation equals time 0 and is defined as first hospital contact with physical presence by the patient, where the patient is registered as actively present in the hospital system included but not restricted to waiting area, emergency room, coronary care unit, internal medicine or other department, depending on country/region.
- (b) Angiographic signs supporting the clinical suspicion of a type 1 MI including but not limited to: A flow-limiting stenosis not present at the site of a prior stent. A relevant stenosis with features suggesting a thrombus/plaque rupture such as luminal irregularities, thrombus-looking appearance, or haziness. Type 1 MI excludes type 2 MI (including but not limited to significant gastrointestinal bleedings, anaemia and sepsis), and type 4 MI (a-c: periprocedural (PCI) MI, stent thrombosis and in-stent restenosis) and type 5 MI (periprocedural (CABG) MI). Interpretation of the above is at the discretion of the investigator.
- (c) If the participant experienced a recent AMI (within 30 days) before the index AMI, investigator must ensure that the current index AMI is considered a new AMI i.e. in a different culprit vessel compared to the recent AMI. This must be confirmed based on angiographic findings. Comparisons of ECG findings between recent AMI and current index AMI is not considered sufficient for the evaluation.
- (d) The sponsor may consider stopping recruitment of STEMI participants if these exceed 40% of the total expected study population
- (e) Known before hospitalisation for index AMI.
- (f) The documented presence of a coronary stent on the coronary angiogram performed for the current (index) AMI is acceptable to define prior coronary revascularisation.
- (g) Defined as 1) previous formal diagnosis of CKD or 2) previous ≥ 2 results of consistently reduced GFR with supplementary information in records supporting that this was in a clinical setting without factors that could affect kidney function (i.e. and not limited to: acute or post-interventions situations or initiation of new medications).
What rules you out
- Use of fibrinolytic therapy for treatment of the current AMI.
- Severe hepatic disease defined as at least one of the following: Previously known or current hepatic encephalopathy (clinical evaluation), Previously known or current ascites (clinical evaluation), Jaundice (clinical evaluation), Previous oesophageal/gastric variceal bleeding, Known hepatic cirrhosis
- Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery [CABG]), non-cardiac surgical, or major endoscopic procedure(b) (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 (c).
- Known (acute or chronic) hepatitis B or hepatitis C (c)
- History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): 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. Participants with TB risk factors (see details in Section 8.2.6)but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2)
- (a) Participants with increased levels of ALT ≤8 x ULN are eligible at the discretion of the investigator if the investigator considers the ALT elevations to be caused by the current AMI. In case the elevation is considered related to other reasons than the current AMI, participants should be excluded when ALT >2.5 x ULN.
- (b) Endoscopic procedure for screening purposes such as gastroscopy and colonoscopy are allowed if there is no suspicion of malignant disease driving the referral.
- (c) Screening for (acute and chronic) hepatitis B and C should focus on health status (reported by participant and clinical examination) and review of already available medical records including laboratory samples, defined as: For hepatitis B: positive HBsAg and/or positive anti-HBc with detectable HBV DNA. Note: participants with positive anti-HBc and undetectable HBV DNA can be enrolled and should, following central laboratory result, be handled according to Section 8.2.7.2. For hepatitis C: positive anti-HCV and detectable HCV RNA.
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV
- Ongoing haemodynamic instability defined as any of the following: Killip Class III or IV, Sustained and/or symptomatic hypotension (systolic blood pressure <90 mmHg)
- Severe kidney impairment defined as any of the following: eGFR <15 mL/min/1.73 m2, Chronic haemodialysis or peritoneal dialysis.
- Known ALT >8 x ULN(a)
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- India
- Mexico
- Brazil
- Canada
- Japan
- Argentina
- China
- Malaysia
- Korea, Republic of
- United Kingdom
- Australia
- Turkey
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; India; Mexico; Brazil; Canada; Japan and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.