BridgeMD
Effects of ziltivekimab on coronary atherosclerotic burden in patients with acute myocardial infarction
EU CTIS ID: 2024-520364-34-00
What this study is testing
To demonstrate the superiority of ziltivekimab vs placebo once-monthly, added to standard of care (SOC) therapy, in inducing favorable effects on change in percent atheroma volume (PAV) in participants with acute myocardial infarction (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
- 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.
- 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
- Hemodynamic stability (as assessed by the treating physician) allowing the repetitive administration of nitroglycerine during the study specific imaging procedure
You likely can't join if
- Female of childbearing potential
- 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).
- Left-main disease, defined as ≥50% 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 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.
- Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation.
- 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.
See the full eligibility criteria
Who can join
- 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.
- 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
- Hemodynamic stability (as assessed by the treating physician) allowing the repetitive administration of nitroglycerine during the study specific imaging procedure
What rules you out
- Female of childbearing potential
- 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).
- Left-main disease, defined as ≥50% 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 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.
- Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation.
- 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.
- 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
- 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 i.v. antibiotics) within the past 12 months, at the discretion of the investigator
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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 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 Switzerland. 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.