Focused Orticumab Research for Treating Inflammation in Coronary Arteries (NCT06927739) | Clinical Trial Compass
RecruitingPhase 2
Focused Orticumab Research for Treating Inflammation in Coronary Arteries
United States240 participantsStarted 2025-08-11
Plain-language summary
The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. The main question it aims to answer is:
Clinical effects of orticumab treatment on inflammation of the coronary artery parameters measured with CCTA
Researchers will compare the effects with placebo group after 6 months of treatment
Participants will Keep the planned study visit appointments Provide complete information about medical and medical history Speak to the study doctor before changing any of non-study treatments, including starting new medications, receiving any vaccinations, or setting out to join any other clinical studies
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization and must adhere to the schedules of activities.
✓. Participant must be \>180 days after presumed type-1 myocardial infarction (i.e., due to plaque rupture or erosion, either STEMI or NSTEMI) without subsequent unstable or severe angina (Canadian Cardiovascular Society Class 3 or 4) at the time of enrollment. Participants who have undergone PCI are allowed.
✓. Participant must be on a stable cardiovascular treatment regimen consistent with local treatment guidelines for post-AMI patients (such as maximally tolerated statin and/or PCSK9 inhibitor medication for LDL reduction, antiplatelet medication, and hypertension treatment).
✓. Participant must have an evaluable, pre-randomization CCTA with one of the following:
✓. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 50th centile (per reference standard) for their age group in at least two coronary arteries or
✓. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 75th centile (per reference standard) for their age group in at least one coronary artery
✓. Participant must have body mass index (BMI) ≤ 40 kg/m2.
What they're measuring
1
Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the 3 coronary arteries (RCA, LAD and LCX) for orticumab compared to placebo at 24 weeks
. Adult male and female participants ≥18 years of age at the Screening Visit:
Exclusion criteria
✕. History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
✕. Percutaneous coronary intervention or invasive diagnostic coronary angiogram planned after screening. Eligible participants who have an invasive diagnostic coronary angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened.
✕. History of or planned coronary artery bypass grafting.
✕. Documented episode of post-MI pericarditis in the 3 months before enrollment.
✕. Presence of unstable or uncontrolled angina. Canadian CV society (CCS) angina class \> 2.
✕. Ongoing New York Heart Association Class IV HF.
✕. Poorly controlled type 1 or type 2 diabetes mellitus (hemoglobin A1c \>8.0%).