[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368168":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":68,"collaborators":71,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":32,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":32,"overallStatus":53,"whyStopped":32,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Cambridge","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Stable CVD - treatment","EXPERIMENTAL","Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to add on therapy with inclisiran + placebo tablet",[13,14],"Drug: Inclisiran","Diagnostic Test: 68Ga-DOTATATE PET-MRI",{"label":16,"type":17,"description":18,"interventionNames":19},"Stable CVD - placebo control","ACTIVE_COMPARATOR","Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to placebo injection + colchicine tablet",[14,20],"Drug: Colchicine",{"label":22,"type":23,"description":24,"interventionNames":25},"HeFH - treatment","PLACEBO_COMPARATOR","Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to placebo injection + placebo tablet",[13,14],[27,33,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Inclisiran","Inclisiran 284 mg, one injection",[22,9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"DIAGNOSTIC_TEST","68Ga-DOTATATE PET-MRI","68Ga-DOTATATE PET-MRI at baseline and 12 weeks",[22,16,9],{"type":28,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Colchicine","Colchicine 500 mcg tablet once daily",[16],[43],{"name":44,"affiliation":5,"role":45},"Jason M Tarkin, MBBS PhD","PRINCIPAL_INVESTIGATOR",[47],{"name":44,"role":48,"phone":49,"phoneExt":32,"email":50},"CONTACT","+44(0)1223331504","jt545@cam.ac.uk",[52],{"facility":5,"status":53,"city":54,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Cambridge","United Kingdom","UK",{"type":58,"coordinates":59},"Point",[60,61],0.11667,52.2,{"lat":61,"lon":60},[64,65],{"name":44,"role":48,"phone":49,"phoneExt":32,"email":50},{"name":66,"role":67,"phone":32,"phoneExt":32,"email":32},"James HF Rudd, MD PhD","SUB_INVESTIGATOR",{"type":45,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Jason Tarkin","Wellcome Clinical Research Career Development Fellow & Honorary Consultant Cardiologist",[72,74,76,79],{"name":73,"class":6},"Cambridge University Hospitals NHS Foundation Trust",{"name":75,"class":6},"Wellcome Trust",{"name":77,"class":78},"GE Healthcare","INDUSTRY",{"name":80,"class":6},"Lund University","100368168","pet-imaging-of-inflammation-and-lipid-lowering-study-100368168",false,"NCT04073797","PET Imaging of Inflammation and Lipid Lowering Study","PIILL","Inclusion Criteria:\n\n* Male or female participants \\>18 years old\n* Able to give written, informed consent and to lie flat\n* Have primary hypercholesterolaemia (non-familial or definite or possible heterozygous familial hypercholesterolaemia (HeFH) based on clinical criteria) or mixed dyslipidaemia, and\n* History of CVD (acute coronary syndrome, coronary or other revascularisation procedures, coronary heart disease, ischaemic stroke, or peripheral arterial disease) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies (see NICE TA 733), and\n* Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and\n* Pre-existing carotid atherosclerotic plaque ≥15mm by B-mode ultrasound\n\nExclusion Criteria:\n\n* Women of childbearing potential not using adequate contraception\n* Contra-indication to MRI scanning\n* Statin-associated myositis or liver function abnormality\n* Already taking inclisiran or colchicine\n* Sensitivity and\u002For contraindication to inclisiran or colchicine. Contraindications to colchicine include severe hepatic or renal impairment, blood disorders, and patients with renal or hepatic impairment who are taking a P-gp inhibitor or a strong CYP3A4 inhibitor\n* Contrast allergy or contrast-nephropathy\n* Chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* Cardiovascular event within 6 months\n* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study\n* Uncontrolled chronic inflammatory disorder\n* History of recent malignancy deemed relevant to the study by the investigator\n* Treatment with medications that result in significant drug to drug interactions with the study medications\n* Current use of systemic corticosteroids or other immunosuppressive drugs\n* Previous or planned carotid endarterectomy surgery or stenting on the index side","ALL","18 Years","99 Years",{"count":92,"type":93},63,"ESTIMATED","INTERVENTIONAL",[96],"NA","While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.",[99,100,101,102],"Hypercholesterolemia","Hypercholesterolemia, Familial","Atherosclerosis","Carotid Artery Plaque","2024-07-18",{"date":105,"type":106},"2024-07-19","ACTUAL",{"date":108,"type":106},"2023-03-20",{"date":110,"type":93},"2026-03-01",{"name":5,"class":6},1]