Actively Recruiting
Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
Led by Massachusetts General Hospital · Updated on 2026-05-13
120
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary goal of this clinical trial is to test the hypothesis that the drug canakinumab (anti-IL-1B monoclonal antibody) decreases vascular inflammation when used by people with a history of coronary artery disease, including those with and without clonal hematopoiesis driven by mutations in TET2.
CONDITIONS
Official Title
Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Prior heart attack or coronary stent procedure more than 180 days before baseline imaging
- Presence of either TET2 clonal hematopoiesis or no CHIP variants on prior sequencing
You will not qualify if you...
- Placement of a drug-eluting stent in a proximal coronary artery less than 180 days before baseline imaging
- Prior coronary artery bypass grafting
- Pregnancy or breastfeeding
- History of blood malignancy or current solid-tumor malignancy
- History of organ or stem cell transplantation
- Current treatment with systemic steroids or anti-inflammatory/immune suppressant therapies (excluding topical, UV, ASA-derivative, or NSAIDs) for autoimmune/inflammatory diseases, post-transplant care, asthma, or pain
- Use of oral steroids or prescription anti-inflammatory/immune suppressant medication for more than 7 days within the past month
- Use of intravenous or intramuscular steroids or anti-inflammatory/immune suppressant medication within the past 3 months
- Known allergy to dextrans, DTPA, radiometals, or severe allergy to iodinated contrast media
- Estimated glomerular filtration rate less than 45 ml/min/1.73 m2
- Contraindications to nitroglycerin, known narrow angle glaucoma, or severe aortic stenosis
- Use of phosphodiesterase type 5 inhibitors without abstaining 5 days prior to scheduled CT angiography
- Significant radiation exposure (40 mSv) within the past 12 months
- Concurrent enrollment in another interfering research study
- Known active or recurrent liver disease or abnormal liver function tests
- History or evidence of tuberculosis or risk factors for tuberculosis
- Active bacterial, fungal, or viral infection or history of recurrent infections
- Suspected or proven immunocompromised state
- Live vaccinations within 3 months before randomization or planned during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Michael C Honigberg, MD MPP
CONTACT
M
Mabel Toribio, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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