Actively Recruiting
Focused Orticumab Research for Treating Inflammation in Coronary Arteries
Led by Abcentra · Updated on 2026-01-27
240
Participants Needed
41
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Focused Orticumab Research for Treating Inflammation in Coronary Arteries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide informed consent and agree to follow all study procedures and schedules.
- Participants must be more than 180 days after a type-1 myocardial infarction (STEMI or NSTEMI) without unstable or severe angina.
- Participants may have undergone percutaneous coronary intervention (PCI).
- Participants must be on a stable cardiovascular treatment regimen following local guidelines for post-AMI care.
- Participants must have a pre-randomization CT coronary angiography (CCTA) showing elevated Fat Attenuation Index (FAI) scores either at or above the 50th percentile in at least two coronary arteries or at or above the 75th percentile in one coronary artery.
- Body mass index (BMI) must be 40 kg/m2 or less.
- Adults 18 years or older.
- Female participants must not be pregnant or lactating and must be postmenopausal, surgically sterilized, or use adequate contraception during and 30 days after the study.
- Male participants with female partners of childbearing potential must use adequate contraception during the study.
You will not qualify if you...
- History of any disease or disorder that could put the participant at risk or affect study results.
- Planned percutaneous coronary intervention or invasive coronary angiogram after screening.
- History or planned coronary artery bypass grafting.
- Post-MI pericarditis within 3 months before enrollment.
- Unstable or uncontrolled angina (Canadian Cardiovascular Society class greater than 2).
- New York Heart Association Class IV heart failure.
- Poorly controlled diabetes (HbA1c greater than 8.0%).
- History or signs of bleeding disorders or high bleeding risk.
- Severe liver disease.
- Ongoing infection, persistent atrial fibrillation/flutter, recent cancer (except non-melanoma skin cancer), substance abuse, severe allergies to biologics or orticumab, positive hepatitis C, hepatitis B or HIV.
- Abnormal lab values as judged by the investigator.
- Blood pressure outside specified safe ranges.
- Contraindications to CCTA including low kidney function, allergy to contrast, history of contrast nephropathy, nitroglycerin contraindication, uncontrolled rapid heart rate, or inability to hold breath.
- Use of certain immune-modifying drugs within 180 days before randomization.
- COVID-19 vaccination or positive test within 90 days of screening.
- Prior exposure to orticumab.
- Legal institutionalization or employment/close relation to sponsor or study staff.
- Participation in other investigational drug/device studies before follow-up end.
AI-Screening
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Trial Site Locations
Total: 41 locations
1
Abcentra Investigational Site
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
Abcentra Investigational Site
Torrance, California, United States, 90502
Actively Recruiting
3
Abcentra Investigational Site
Boca Raton, Florida, United States, 33434
Actively Recruiting
4
Abcentra Investigational Site
Richmond, Indiana, United States, 47374
Actively Recruiting
5
Abcentra Investigational Site
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
6
Abcentra Investigational Site
Baltimore, Maryland, United States, 21215
Actively Recruiting
7
Abcentra Investigational Site
Midland, Michigan, United States, 48670
Actively Recruiting
8
Abcentra Investigational Site
Ostrava, Moravian-Silesian Region, Czechia, 728 80
Actively Recruiting
9
Abcentra Investigational Site
Pilsen, Plzeň Region, Czechia, 323 00
Actively Recruiting
10
Abcentra Investigational Site
Prague, Praha 2, Czechia, 128 08
Actively Recruiting
11
Abcentra Investigational Site
Prague, Praha 4, Czechia, 140 21
Actively Recruiting
12
Abcentra Investigational Site
Brno, South Moravian, Czechia, 602 00
Actively Recruiting
13
Abcentra Investigational Site
Pécs, Baranya, Hungary, 7635
Actively Recruiting
14
Abcentra Investigational Site
Budapest, Central Hungary, Hungary, 1036
Actively Recruiting
15
Abcentra Investigational Site
Budapest, Central Hungary, Hungary, 1094
Actively Recruiting
16
Abcentra Investigational Site
Budapest, Central Hungary, Hungary, 1132
Actively Recruiting
17
Abcentra Investigational Site
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
Actively Recruiting
18
Abcentra Investigational Site
Caserta, Campania, Italy, 81100
Actively Recruiting
19
Abcentra Investigational Site
Ferrara, Ferrara, Italy, 44124
Actively Recruiting
20
Abcentra Investigational Site
Brescia, Lombardy, Italy, 25123
Actively Recruiting
21
Abcentra Investigational Site
Milan, Lombardy, Italy, 20162
Actively Recruiting
22
Abcentra Investigational Site
Pavia, Lombardy, Italy, 27100
Actively Recruiting
23
Abcentra Investigational Site
Krakow, Lesser Poland Voivodeship, Poland, 30-082
Actively Recruiting
24
Abcentra Investigational Site
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
25
Abcentra Investigational Site
Warsaw, Masovian Voivodeship, Poland, 03-505
Actively Recruiting
26
Abcentra Investigational Site
Baia Mare, Maramureş, Romania, 430031
Actively Recruiting
27
Abcentra Investigational Site
Târgu Mureş, Mureș County, Romania, 540124
Actively Recruiting
28
Abcentra Investigational Site
Timișoara, Timiș County, Romania, 300060
Actively Recruiting
29
Abcentra Investigational Site
Córdoba, Andalusia, Spain, 14004
Actively Recruiting
30
Abcentra Investigational Site
Madrid, Madrid, Spain, 28034
Actively Recruiting
31
Abcentra Investigational Site
Madrid, Madrid, Spain, 28046
Actively Recruiting
32
Abcentra Investigational Site
El Palmar, Murcia, Spain, 30120
Actively Recruiting
33
Abcentra Investigational Site
Seville, Sevilla, Spain, 41009
Actively Recruiting
34
Abcentra Investigational Site
Danderyd, Stockholm County, Sweden, 182 88
Actively Recruiting
35
Abcentra Investigational Site
Solna, Stockholm County, Sweden, 171 76
Actively Recruiting
36
Abcentra Investigational Site
Gothenburg, Västra Götaland County, Sweden, 413 45
Actively Recruiting
37
Abcentra Investigational Site
London, Greater London, United Kingdom, EC1M 6BQ
Actively Recruiting
38
Abcentra Investigational Site
Manchester, Greater Manchester, United Kingdom, M23 9LT
Actively Recruiting
39
Abcentra Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
40
Abcentra Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
Actively Recruiting
41
Abcentra Investigational Site
Sheffield, South Yorkshire, United Kingdom, S57AU
Actively Recruiting
Research Team
A
Abcentra
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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