ZILTIVEKIMAB for Acute myocardial infarction

Inclusion criteria

• {"criterion_text":"- Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with PCI within 48 hours: a. Acute ST-segment elevation myocardial infarction (STEMI) with all of the following: i. Onset of relevant pain suggestive of cardiac ischemia within ≤24h of index angiography ii. 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 b. Non-ST segment elevation myocardial infarction (NSTEMI), with rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.\n- At least two major native coronary arteries (“study vessels”) each meeting the following criteria for intracoronary imaging immediately following the qualifying Percutaneous Coronary Intervention (PCI) procedure: a. Angiographic evidence of a reduction in lumen diameter between >20 and <50% by angiographic visual estimation b. Study vessel deemed to be accessible to imaging catheters and suitable for intracoronary imaging in the proximal (50 mm) segment (“study segment”) c. Study vessel may not be a bypass (saphenous vein or arterial) graft or a bypassed native vessel d. Study vessel must not have undergone previous PCI within the study segment e. A vessel which is candidate for intervention at the time of qualifying PCI or over the following 6 months in the judgment of the Investigator, cannot be a study vessel\n- Hemodynamic stability (as assessed by the treating physician) allowing the repetitive administration of nitroglycerine during the study specific imaging procedure"}

Exclusion criteria

• {"criterion_text":"- Female of childbearing potential\n- 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).\n- Left-main disease, defined as ≥50% reduction in lumen diameter of the left main coronary artery by angiographic visual estimation\n- Three-vessel disease, defined as the presence of severe or significant CAD on the basis of angiography, imaging, or physiology, in all three major epicardial territories (including major branches) that have an indication for revascularization or are too advanced to be treated.\n- Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation.\n- Severe kidney impairment defined as any of the following a. Previous or current estimated glomerular filtration rate <30 ml/min/1.73m2 b. Chronic haemodialysis or peritoneal dialysis.\n- Active liver disease or hepatic dysfunction 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 hepatitis cirrhosis\n- Known, or suspicion of, active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator\n- History of recurrent serious infections (infections leading to hospitalization or use of i.v. antibiotics) within the past 12 months, at the discretion of the investigator\n- Presence of risk factors for tuberculosis (TB) or history or evidence of latent TB such as (but not limited to): History or evidence of a positive TB test or chest X-ray compatible with prior TB and TB treatment initiated less than 28 days prior to randomisation"}

Primary endpoints

• {"endpoint_text":"- Change in percent atheroma volume (PAV) as determined by greyscale IVUS in matched regions of interest. Measured from randomisation to end-of-study.","definition_or_measurement_approach":"Determined by greyscale intravascular ultrasound (IVUS) in matched regions of interest; measured from randomisation to end-of-study."}

Secondary endpoints

• {"endpoint_text":"- Change in maximum lipid core burden index (LCBI) in any 4-mm segment (maxLCBI4mm) as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study.","definition_or_measurement_approach":"Determined by Near Infrared Spectroscopy (NIRS) in matched regions of interest; measured from randomisation to end-of-study."}
• {"endpoint_text":"- Change in minimal fibrous cap thickness as determined by OCT in matched regions of interest. Measured from randomisation to end-of-study.","definition_or_measurement_approach":"Determined by Optical Coherence Tomography (OCT) in matched regions of interest; measured from randomisation to end-of-study."}
• {"endpoint_text":"- Change in LCBI total as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study.","definition_or_measurement_approach":"Determined by NIRS in matched regions of interest; measured from randomisation to end-of-study."}
• {"endpoint_text":"- Change in average angular extension (AAE) of macrophages as determined by OCT in matched regions of interest. Change in LCBI total as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study.","definition_or_measurement_approach":"AAE determined by OCT and LCBI total determined by NIRS in matched regions of interest; measured from randomisation to end-of-study."}
• {"endpoint_text":"- Change in normalized total atheroma volume (NTAV) by IVUS in matched regions of interest. Measured from randomisation to end-of-study.","definition_or_measurement_approach":"Determined by IVUS in matched regions of interest; measured from randomisation to end-of-study."}
• {"endpoint_text":"- Change in mean fibrous cap thickness as determined by OCT in matched regions of interest. Measured from randomisation to end-of-study.","definition_or_measurement_approach":"Determined by OCT in matched regions of interest; measured from randomisation to end-of-study."}
• {"endpoint_text":"- Change in IL-6. Measured from randomisation to week 4 and week 52.","definition_or_measurement_approach":"IL-6 biomarker levels measured at baseline (randomisation), week 4, and week 52."}
• {"endpoint_text":"- Change in hs-CRP. Measured from randomisation to to week 4 and week 52.","definition_or_measurement_approach":"High-sensitivity C-reactive protein (hs-CRP) measured at baseline (randomisation), week 4, and week 52."}
• {"endpoint_text":"- Change in hs-TnT . Measured from randomisation to week 4 and week 52.","definition_or_measurement_approach":"High-sensitivity troponin T measured at baseline (randomisation), week 4, and week 52."}
• {"endpoint_text":"- Change in NT-pro-BNP . Measured from randomisation to week 4 and week 52.","definition_or_measurement_approach":"NT-pro-BNP measured at baseline (randomisation), week 4, and week 52."}
• {"endpoint_text":"- Change in lipid and inflammatory markers. Measured from randomisation to week 4 and week 52.","definition_or_measurement_approach":"Lipid and inflammatory biomarker panels measured at baseline (randomisation), week 4, and week 52."}
• {"endpoint_text":"- Time to first occurrence of: All-cause death Cardiac death Non-fatal spontaneous myocardial infarction Any coronary revascularizationa Non-fatal stroke Transient ischemic attack Measured from randomisation to end-of-study.","definition_or_measurement_approach":"Time-to-event analysis for composite and individual cardiovascular outcomes measured from randomisation to end-of-study."}

Methods

• Recruitment arrangements documents are listed for each participating country (country-specific recruitment arrangements and SI-IC documents available), but explicit recruitment channels, methods, or country-specific recruitment approaches are not described in the provided data.

Austria

Earliest CTIS Part Ii Submission Date

24-09-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

26

Number Of Sites

1

Number Of Participants

28

Spain

Earliest CTIS Part Ii Submission Date

15-07-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

97

Number Of Sites

2

Number Of Participants

28

Netherlands

Earliest CTIS Part Ii Submission Date

29-09-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

21

Number Of Sites

2

Number Of Participants

28

Denmark

Earliest CTIS Part Ii Submission Date

17-09-2025

Latest Decision Or Authorization Date

13-10-2025

Processing Time Days

26

Number Of Sites

2

Number Of Participants

55

Italy

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

15-10-2025

Processing Time Days

30

Number Of Sites

6

Number Of Participants

110

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

4G Clinical B.V.

Responsibilities

Patient randomization and study drug supply

Name

Cardialysis B.V.

Responsibilities

Clinical Research Organization: eCRF development, site management and monitoring, CEC coordination; Core laboratory functions (IVUS and NIRS)

Third parties

• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"Patient randomization and study drug supply","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Cardialysis B.V.","duties_or_roles":"Clinical Research Organization: eCRF development, site management and monitoring, CEC coordination. Core laboratory: Intra-Vascular Ultrasound (IVUS) and Near Infrared Spectroscopy (NIRS)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"AG Mednet Inc.","duties_or_roles":"Electronic Data Transfer System (Imaging)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"University Hospital Zurich","duties_or_roles":"Efficacy laboratory assessments","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"EvidentlQ Germany GmbH","duties_or_roles":"eCRF","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Insel Gruppe AG","duties_or_roles":"Academic Clinical Trials Unit: catheters management and distribution, data cleaning support, and statistical programming and reporting. Core Laboratory: Optical coherence tomography (OCT)","organisation_type":"Hospital/Clinic/Other health care facility"}

Co-sponsors

• ECRI-trials B.V.