[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ECRI bv\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100614183","phase-3-effects-of-ziltivekimab-on-coronary-atherosclerotic-burden-in-patients-with-acute-myocardial-infarction-100614183",false,"NCT07276282","Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction","Effects of Ziltivekimab Versus Placebo on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-infrared Spectroscopy and Optical Coherence Tomography Imaging Study","ZEPHYR","Key Inclusion Criteria:\n\n* Informed consent obtained before any study-related activities.\n* Age 18 years or above at the time of providing informed consent.\n* Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with PCI.\n* At least two major native coronary arteries each meeting angiographic criteria for intracoronary imaging immediately following the qualifying PCI procedure.\n\nKey Exclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.\n* Female of childbearing potential.\n* Left-main disease.\n* Three-vessel disease.\n* History of coronary artery bypass surgery.\n* TIMI flow \\\u003C2 of the infarct-related artery after PCI.\n* Unstable clinical status (hemodynamic or electrical instability.\n* Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation.\n* Uncontrolled cardiac arrhythmia.\n* Severe kidney impairment.\n* Active liver disease or hepatic dysfunction.\n* Current use of anti-IL-6 products or anticipated use of such drugs any time during the study.\n* Use of systemic immunosuppressive drugs or disease modifying anti-rheumatic drugs or anticipated chronic use of such drugs any time during the study.\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.\n* Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals.\n* Known (acute or chronic) hepatitis B or hepatitis C\n* Planned surgery within 12 months from the time of screening.\n* 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\u002Fhigh grade prostatic intraepithelial neoplasia (PIN) at the discretion of the investigator.\n* Estimated life expectancy less than 2 years\n* 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.\n* Major cardiac surgical within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG).","ALL","18 Years",{"count":20,"type":21},332,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.\n\nThis 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.\n\nThis 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.\n\nThe 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.",[27,28,29],"Coronary Artery Disease","Acute Myocardial Infarction (AMI)","Coronary Atherosclerosis of Native Coronary Artery",[31,32,33,34,35],"IL-6 inhibition","atherosclerosis","acute myocardial infarction","anti-inflammatory","intracoronary imaging","RECRUITING","2026-03-20",{"date":39,"type":40},"2026-03-23","ACTUAL",{"date":42,"type":40},"2025-12-19",{"date":44,"type":21},"2028-12-01",{"name":46,"class":47},"ECRI bv","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100564178","ivus-chip-upp-registry-100564178","NCT06625801","IVUS CHIP UPP Registry","Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures in Underrepresented Patient Populations Registry","Inclusion Criteria:\n\n1. The patient must be ≥18 years of age and self-identify within a US census-defined minority\n2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:\n\n   1. Angiographic heavy calcification\n   2. Ostial lesions\n   3. True bifurcation lesions involving side-branches \\>2.5mm\n   4. Left main lesions\n   5. Chronic total occlusion\n   6. In-stent restenosis\n   7. Long-lesions (estimated stent length \\> 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI\n3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)\n4. All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons\n5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion\n6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he\u002Fshe (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB\n\nExclusion Criteria:\n\n1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days\n2. Known untreated severe valvular heart disease\n3. Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)\n4. Requiring PCI in a diseased aorto-coronary bypass\n5. Known contraindication or hypersensitivity to anticoagulants\n6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors\n7. Non-cardiac co-morbidities with a life expectancy less than 1 year\n8. A patients that is currently participating in a clinical trial that has not yet reached its primary endpoint cannot be included in this registry. A patient may only be enrolled in this registry once.",{"count":57,"type":21},1010,"24 Months","OBSERVATIONAL","The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women. All patients will be treated with IVUS-guided PCI.",[27,62,63],"Coronary Artery Disease Risk High","Complex Coronary Artery Disease",[65,66,67,68],"PCI","intravascular ultrasound","CHIP","ivus-guidance","NOT_YET_RECRUITING","2025-08-25",{"date":72,"type":40},"2025-09-02",{"date":74,"type":21},"2025-09",{"date":76,"type":21},"2029-03",{"name":46,"class":47},""]