[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569205":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":64,"collaborators":67,"id":75,"slug":25,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":25,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo: Control","PLACEBO_COMPARATOR","Participants with and without TET2 CHIP will receive placebo injection every 3 months for 4 doses as part of the randomized clinical trial part of this proposal.",[13],"Drug: Saline (NaCl 0,9 %) (placebo)",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment: Canakinumab","EXPERIMENTAL","Participants with and without TET2 CHIP will receive 150mg of canakinumab every 3 months for 4 doses as part of the randomized clinical trial part of this proposal.",[19],"Drug: CANAKINUMAB (ILARIS®)",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DRUG","CANAKINUMAB (ILARIS®)",[15],null,{"type":22,"name":27,"description":11,"armGroupLabels":28,"otherNames":25},"Saline (NaCl 0,9 %) (placebo)",[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Michael C Honigberg, MD MPP","CONTACT","617-726-1843","mhonigberg@mgh.harvard.edu",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Mabel Toribio, MD","(617)-724-2826","mptoribio@mgh.harvard.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Boston","Massachusetts","02114","United States",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53,57,61],{"name":54,"role":32,"phone":55,"phoneExt":25,"email":56},"Victoria R Viscosi, MS","617-724-2996","vviscosi@mgh.harvard.edu",{"name":58,"role":32,"phone":59,"phoneExt":25,"email":60},"Jack H.A. Miller, BS","617-643-7546","jmiller90@mgh.harvard.edu",{"name":62,"role":63,"phone":25,"phoneExt":25,"email":25},"Michael C Honigberg, MD, MPP","PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Michael C. Honigberg","MD, MPP",[68,71,73],{"name":69,"class":70},"National Institutes of Health (NIH)","NIH",{"name":72,"class":6},"Broad Institute of MIT and Harvard",{"name":74,"class":6},"Yale University","100569205",false,"NCT06691217","Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis","TECTONIC","Inclusion Criteria:\n\n* 18 years or older\n* 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)\n* Presence of either TET2 mutations or no myeloid driver mutations on prior sequencing\n\nExclusion Criteria:\n\n* placement of a drug-eluting stent in a proximal coronary arterial segment \\\u003C180 days before baseline imaging\n* prior coronary artery bypass grafting\n* pregnancy or breastfeeding\n* history of blood malignancy or current solid-tumor malignancy\n* history of organ or stem cell transplantation\n* current treatment with prescription, systemic (oral, IV \\[intravenous\\], or IM \\[intramuscular\\]) steroids or anti-inflammatory\u002Fimmune suppressant medical therapies (including colchicine but excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune\u002Finflammatory diseases, post-transplant care, asthma, or pain\n* use of oral steroids or prescription oral anti-inflammatory\u002Fimmune suppressant medication for \\>7 days within the past 1 month\n* use of IV or IM steroids or IV or IM anti-inflammatory\u002Fimmune suppressant medication within the past 3 months\n* known allergy to dextran's and\u002For DTPA and\u002For radiometals and\u002For severe allergy to iodinated contrast media\n* estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73 m2\n* contraindications to nitroglycerin known narrow angle glaucoma, or known severe aortic stenosis\n* use of phosphodiesterase type 5 inhibitor AND refusal to abstain from use of these medications within the 5 days prior to scheduled CCTA scan\n* significant radiation exposure (40msV) received within the past 12 months\n* concurrent enrollment in another research study judged by the investigators to interfere with the current study\n* known active or recurrent hepatic disease (including cirrhosis or ALT\u002FAST levels \\>3 times the upper limit oof or total bilirubin \\>2 times the upper limits of normal)\n* history or evidence of tuberculosis (TB) (active or latent) infection or risk factor for TB\n* active bacterial, fungal or viral infection at the time of enrollment or history of recurrent infections\n* suspected or proven immunocompromised state\n* live vaccinations within 3 months prior to randomization visit or live vaccinations planned during the trial","ALL","18 Years",{"count":84,"type":85},120,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","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.",[91,92,93],"Vascular Inflammation","ASCVD","ASCVD Management",[95,96,97,91,92,98],"CHIP","TET2 CHIP","Clonal Hematopoiesis","ASCVD management","2026-06-16",{"date":101,"type":102},"2026-06-18","ACTUAL",{"date":104,"type":102},"2026-03-24",{"date":106,"type":85},"2030-04-01",{"name":5,"class":6},1]