A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants With Prior Myocardial Infarction Who Have Elevated Coronary Inflammation Based on FAI Score Assessed by CCTA
Abcentra
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
Description
Participants will have the opportunity to participate in a Day 14 sub study. Participants who enroll in this optional sub study will have safety assessment (AE monitoring) and a blood sample obtained for serum orticumab concentration measurement, ADA titer, clinical safety labs and cardiometabolic and inflammation biomarkers.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. 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. 3. Participant must be on a stable cardiovascular treat…
Interventions
- DrugOrticumab
Orticumab treatment for 24 weeks for post MI population
- DrugPlacebo
Placebo for 24 weeks for the post MI population
Locations (41)
- Abcentra Investigational SiteLos Angeles, California
- Abcentra Investigational SiteTorrance, California
- Abcentra Investigational SiteBoca Raton, Florida
- Abcentra Investigational SiteRichmond, Indiana
- Abcentra Investigational SiteLouisville, Kentucky
- Abcentra Investigational SiteBaltimore, Maryland