Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction

NCT07276282 | Recruiting Phase 3

• 3 other identifiers: ECRI-162024-520364-34-00NN6018-8195
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

Despite improvements in the treatment, coronary artery disease (CAD) remains one of the leading causes of death worldwide. Around 20% of people who have suffered a heart attack (myocardial infarction) need to be hospitalized again within a year, and 10% experience another heart attack. Despite currently available medication, patients remain at risk of further episodes after a heart attack. Scientists have discovered that inflammation in the body plays a decisive role in the development and narrowing of arterial blockages (atherosclerosis). This study aims to investigate whether a new treatment that reduces inflammation can help improve the arteries of patients with CAD. This study will examine whether blocking certain inflammation-related substances with a new medicinal product called ziltivekimab affects the buildup and composition of plaques (fatty deposits) in the coronary arteries. Special imaging diagnostic techniques will be used to look inside the arteries and check whether the treatment helps reduce the narrowing caused by dangerous plaques, which can lead to future heart attacks. This is a clinical study in which participants are randomly divided into two groups (randomization): one group will receive the new treatment ziltivekimab and other group will receive a placebo (a harmless substance with no active ingredients). Both groups will continue to receive standard treatment for heart attacks. The study lasts approximately 15 months per participant. The full scientific title of the trial is: Effects of ziltivekimab versus placebo on coronary atherosclerosis in patients with acute myocardial infarction. A study with serial multi-vessel imaging obtained using intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography techniques.

Conditions

Coronary Artery Disease; Acute Myocardial Infarction (AMI); Coronary Atherosclerosis of Native Coronary Artery

Keywords

IL-6 inhibition; atherosclerosis; acute myocardial infarction; anti-inflammatory; intracoronary imaging

Outcome Measures

Primary Outcomes (1)

• Change in percent atheroma volume

  Change in percent atheroma volume (PAV) as determined by greyscale intravascular ultrasound (IVUS) in matched regions of interest. Theoretical change is between -100% to +100%. Typical range around -2% to +2%. A lower (more negative) change in PAV is better.

  From randomization (week 0) to end-of-study (52-week)

Secondary Outcomes (2)

• Maximum lipid core burden index

  From randomisation (week 0) to end-of-study (52-week)

• Minimal fibrous cap thickness

  From randomisation (week 0) to end-of-study (52-week)

Study Arms (2)

Ziltivekimab Arm

EXPERIMENTAL

Participants will receive Ziltivekimab subcutaneously once per month

Drug: Ziltivekimab

Placebo Arm

PLACEBO COMPARATOR

Participants will receive placebo subcutaneously once per month

Drug: Placebo

Interventions

Placebo DRUG

Placebo is administered subcutaneously (i.e., under the skin) once per month added to standard of care.

Placebo Arm

Ziltivekimab DRUG

Ziltivekimab is administered subcutaneously (i.e., under the skin) once per month added to standard of care.

Ziltivekimab Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any study-related activities.
• Age 18 years or above at the time of providing informed consent.
• Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with PCI.
• At least two major native coronary arteries each meeting angiographic criteria for intracoronary imaging immediately following the qualifying PCI procedure.

You may not qualify if:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.
• Female of childbearing potential.
• Left-main disease.
• Three-vessel disease.
• History of coronary artery bypass surgery.
• TIMI flow \<2 of the infarct-related artery after PCI.
• Unstable clinical status (hemodynamic or electrical instability.
• Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation.
• Uncontrolled cardiac arrhythmia.
• Severe kidney impairment.
• Active liver disease or hepatic dysfunction.
• Current use of anti-IL-6 products or anticipated use of such drugs any time during the study.
• Use of systemic immunosuppressive drugs or disease modifying anti-rheumatic drugs or anticipated chronic use of such drugs any time during the study.
• Known, or suspicion of, active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator

Sponsors & Collaborators

• ECRI bv: lead
• Novo Nordisk A/S: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Cardialysis B.V.: collaborator

Study Sites (1)

Bern University Hospital, Inselspital Bern

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

ziltivekimab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lorenz Räber, MD, PhD

  Cardiology Department, Bern University Hospital, Inselspital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Ernest Spitzer, MD

  European Cardiovascular Research Institute

  STUDY DIRECTOR

Central Study Contacts

Anita Dekker

CONTACT

31102062828; adekker@cardialysis.nl

Ernest Spitzer, MD

CONTACT

31102062828; e.spitzer@ecri-trials.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical Research Organization, Data Coordinating Center, Core Laboratories
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)