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Compares treatment options for Myocardial Infarction
Official title A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack
ClinicalTrials.gov ID: NCT07301034
What this study is testing
What is Ziltivekimab?
Ziltivekimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is testing the effect of ziltivekimab on reducing plaque in the blood vessels of the heart, specifically aiming to manage or reduce atherosclerotic plaque. The purpose of the study is to determine whether ziltivekimab can effectively reduce this plaque.
- Phase 3: a large, late-stage study
- Time commitment: about 15 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study...
- 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 percutaneous coronary intervention (PCI): a. Acute...
- At least two major native coronary arteries ‡ ("study vessels") each meeting the following criteria for intracoronary imaging immediately following...
- Angiographic evidence of a reduction in lumen diameter between \>20 and \<50 percent (%) by angiographic visual estimation.
You likely can't join if
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.
- Previous participation in this study. Participation is defined as randomisation.
- Female of childbearing potential.
- Participation in any other treatment or imaging clinical study within the past 30 days, or as parallel inclusion during the index hospitalization.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
See the full eligibility criteria
Who can join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- 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 percutaneous coronary intervention (PCI): a. Acute ST-segment elevation myocardial infarction (STEMI) with all of the...
- At least two major native coronary arteries ‡ ("study vessels") each meeting the following criteria for intracoronary imaging immediately following the qualifying PCI procedure:
- Angiographic evidence of a reduction in lumen diameter between \>20 and \<50 percent (%) by angiographic visual estimation.
- Study vessel deemed to be accessible to imaging catheters and suitable for intracoronary imaging in the proximal (50 millimeter [mm]) segment ("study segment").
- Study vessel may not be a bypass (saphenous vein or arterial) graft or a bypassed native vessel.
- Study vessel must not have undergone previous PCI within the study segment.
- 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. 5\. Hemodynamic stability (as assessed by the...
What rules you out
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.
- Previous participation in this study. Participation is defined as randomisation.
- Female of childbearing potential.
- Participation in any other treatment or imaging clinical study within the past 30 days, or as parallel inclusion during the index hospitalization.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Left-main disease, defined as \>=50 percent (%) reduction in lumen diameter of the left main coronary artery by angiographic visual estimation
- Three-vessel disease, defined as the presence of severe or significant coronary artery disease (CAD) on the basis of angiography, imaging, or physiology, in all three major epicardial territories (including major...
- History of coronary artery bypass surgery
- Thrombolysis In Myocardial Infarction (TIMI) flow \<2 of the infarct-related artery after PCI
- Unstable clinical status (hemodynamic or electrical instability. Hemodynamic instability defined as any of the following: Killip Class III or IV. Sustained and/or symptomatic hypotension (as assessed by the treating...
- Significant coronary calcification or tortuosity deemed to preclude Intra-Vascular Ultrasound (IVUS), Near Infrared Spectroscopy (NIRS) and Optical Coherence Tomography (OCT) evaluation.
- Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 months prior to screening.
- Severe kidney impairment defined as any of the following: Previous or current estimated glomerular filtration rate \<30 milliliters per minute (ml/min) /1.73 square meter (m\^2) Chronic haemodialysis or peritoneal...
- Current use of anti-interleukin (IL)-6 products or anticipated use of such drugs any time during the study.
- Use of systemic immunosuppressive drugs (both small molecules and biologics) or disease modifying anti-rheumatic drugs (DMARDs including both biologic DMARDs like anti- TNFalpha and conventional DMARDs like...
- Known, or suspicion of, active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator.
- History of recurrent serious infections (infections leading to hospitalization or use of intravenous (i.v.) antibiotics) within the past 12 months, at the discretion of the investigator.
- Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals (Note: "Systemic" is defined as oral or i.v. drugs that are absorbed into the circulation. Antibiotics used to treat latent TB are...
- Absolute neutrophil count \<2x10 10\^9/L
- Absolute platelet count \< 120 x10\^9/L
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>8 × upper limit of normal. Participants with increased levels of ALT or AST \ 2.5 x(ULN).
- Known (acute or chronic) hepatitis B or hepatitis C
- Planned surgery within 12 months from the time of screening.
- History of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, low risk prostate cancer, or carcinoma in situ/high grade prostatic...
- Estimated life expectancy less than 2 years
- 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 latent TB and TB treatment...
- Diagnosis of human immunodeficiency virus (HIV).
- History of gastrointestinal perforation (Note: History of perforated appendicitis more than 5 years old is not exclusionary).
- History of active diverticulitis within the past 5 years.
- History of inflammatory bowel disease that has been clinically active within the past 12 months.
- History of bone marrow or solid organ transplant or anticipated to receive an organ transplant during the study.
- Received a live or attenuated-live vaccine product within 4 weeks of study intervention administration or expected to receive a live or attenuated-live vaccine product during the treatment period.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Gistrup, Denmark
- København Ø, Denmark
- Rome, Lazio, Italy
- Bergamo, Lombardy, Italy
- Messina, Sicily, Italy
- Rivoli, To, Italy
- Genova, Italy
- Novara, Italy
- Orbassano, Italy
- Rome, Italy
- San Donato Milanese, Italy
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Madrid, Spain
- Santander, Spain
- Basel, Switzerland
- Bern, Switzerland
- Geneva, Switzerland
- Lucerne, Switzerland
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 study runs about 15 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Gistrup, Denmark; København Ø, Denmark; Rome, Lazio, Italy; Bergamo, Lombardy, Italy; Messina, Sicily, Italy and 14 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 ClinicalTrials.gov; the study team decides eligibility.