Can a drug calm heart inflammation in people with TET2 mutations?
NCT ID NCT06691217
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether canakinumab, an anti-inflammatory drug, can reduce blood vessel inflammation in people with coronary artery disease. Some participants have a genetic change called TET2 clonal hematopoiesis, which may increase inflammation. 120 adults will receive either canakinumab or a placebo every 3 months for a year, and researchers will measure changes in artery inflammation using CT scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- canakinumab (Ilaris)
- What this could lead to
- If successful, this could point toward a targeted treatment to reduce heart inflammation in people with certain genetic mutations.
- What could go wrong
- This is a small Phase 2 trial, so results may not confirm benefit. The drug can increase infection risk, and the effect on heart attacks is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years or older * Coronary artery disease, defined as prior heart attack, coronary stent procedure \>180 days before baseline imaging, or advanced subclinical coronary atherosclerosis (coronary artery calcium score ≥300 Agatston units, CAD-RADS 3 or greater atherosclerosis on coronary CT angiography, or qualitatively severe coronary artery calcification identified on non-gated CT imaging) * Presence of either TET2 mutations or no myeloid driver mutations on prior sequencing Exclusion Criteria: * placement of a drug-eluting stent in a proximal coronary arterial segment \<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 prescription, systemic (oral, IV \[intravenous\], or IM \[intramuscular\]) steroids or anti-inflammatory/immune suppressant medical therapies (including colchicine but excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune/inflammatory diseases, post-transplant care, asthma, or pain * use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \>7 days within the past 1 month * use of IV or IM steroids or IV or IM anti-inflammatory/immune suppressant medication within the past 3 months * known allergy to dextran's and/or DTPA and/or radiometals and/or severe allergy to iodinated contrast media * estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73 m2 * contraindications to nitroglycerin known narrow angle glaucoma, or known severe aortic stenosis * use of phosphodiesterase type 5 inhibitor AND refusal to abstain from use of these medications within the 5 days prior to scheduled CCTA scan * significant radiation exposure (40msV) received within the past 12 months * concurrent enrollment in another research study judged by the investigators to interfere with the current study * known active or recurrent hepatic disease (including cirrhosis or ALT/AST levels \>3 times the upper limit oof or total bilirubin \>2 times the upper limits of normal) * history or evidence of tuberculosis (TB) (active or latent) infection or risk factor for TB * active bacterial, fungal or viral infection at the time of enrollment or history of recurrent infections * suspected or proven immunocompromised state * live vaccinations within 3 months prior to randomization visit or live vaccinations planned during the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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