临床试验/2023-506876-28-00

2023-506876-28-00招募中3 期

ARTEMIS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction.

Novo Nordisk A/S233 个研究点分布在 2 个国家目标入组 3,909 人开始时间: 2024年8月15日最近更新: 2026年8月19日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: Novo Nordisk A/S
入组人数: 3,909
试验地点: 233
主要终点: (b) including undetermined cause of death

研究概览入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

入排标准

年龄范围: 18 years 至 65+ years（65+ Years, 18-64 Years）
接受健康志愿者: 否

入选标准

•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).

排除标准

•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.
•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)

研究组 & 干预措施

Ziltivekimab

Placebo

干预措施: Ziltivekimab (Drug)

ziltivekimab

Test

干预措施: ziltivekimab (Drug)

结局指标

主要结局

(b) including undetermined cause of death

(d) including ischaemic, haemorrhagic and undetermined stroke

Number of CV death (a,b), non-fatal MI (a,c) or non-fatal stroke (a,d)

Time to first occurrence of a composite MACE endpoint consisting of: All-cause mortality (a,b), Non-fatal MI (a,c), Non-fatal stroke (a,d)

Time to first occurrence of a 3-component MACE endpoint comprising: CV death (a,b), Non-fatal MI (a,c), Non-fatal stroke (a,d)

Number of all-cause mortality (a,b), non-fatal MI (a,c) or non-fatal stroke (a,d)

Time to first occurrence of non-fatal MI (a,c)

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

Time to first occurrence of non-fatal stroke (a,d)

Time to first occurrence of stroke (d) (fatal and non-fatal (a))

(a) Based on EAC-confirmed events

次要结局

(b) including undetermined cause of death
(c) acute MI only
(d) including ischaemic, haemorrhagic and undetermined stroke
Time to first occurrence of a 3-component coronary MACE endpoint comprising: CV death (a,b), Non-fatal MI (a,c), Ischaemia-driven coronary revascularisation
Time to first occurrence of a 5-component expanded MACE endpoint comprising: CV death (a,b), non-fatal MI (a,c), non-fatal stroke (a,d), Ischaemia-driven coronary revacularisation, HF hospitalisation (a) or urgent HF visit (a)
Time to first occurrence of a 3-component HF endpoint comprising: CV death (a,b), HF hospitalisation (a) or urgent HF visit (a), Outpatient HF visit (a)
Time to occurrence of CV death (a,b)
Time to occurrence of all-cause death (a,b)
(a) Based on EAC-confirmed events

研究者

发起方

Novo Nordisk A/S

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

EU submission Hub

Scientific

Novo Nordisk A/S

研究点 (233)

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