[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569205":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":65,"collaborators":68,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"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,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.05977,42.35843,{"lat":51,"lon":50},[54,58,62],{"name":55,"role":32,"phone":56,"phoneExt":25,"email":57},"Victoria R Viscosi, MS","617-724-2996","vviscosi@mgh.harvard.edu",{"name":59,"role":32,"phone":60,"phoneExt":25,"email":61},"Jack H.A. Miller, BS","617-643-7546","jmiller90@mgh.harvard.edu",{"name":63,"role":64,"phone":25,"phoneExt":25,"email":25},"Michael C Honigberg, MD, MPP","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Michael C. Honigberg","MD, MPP",[69,72,74],{"name":70,"class":71},"National Institutes of Health (NIH)","NIH",{"name":73,"class":6},"Broad Institute of MIT and Harvard",{"name":75,"class":6},"Yale University","100569205","phase-2-effects-of-il-1-beta-inhibition-on-vascular-inflammation-in-tet2-clonal-hematopoiesis-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":86,"type":87},120,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93,94,95],"Vascular Inflammation","ASCVD","ASCVD Management",[97,98,99,93,94,100],"CHIP","TET2 CHIP","Clonal Hematopoiesis","ASCVD management","2026-06-16",{"date":103,"type":104},"2026-06-18","ACTUAL",{"date":106,"type":104},"2026-03-24",{"date":108,"type":87},"2030-04-01",{"name":5,"class":6},1]