[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552164":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":18,"responsibleParty":39,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":18,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":18,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":18},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose colchicine 0.5mg OD","EXPERIMENTAL","Low dose colchicine 0.5mg OD for 6 months",[13],"Drug: Colchicine 0.5 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Guideline directed therapy","NO_INTERVENTION","Guideline directed therapy; participants will be maintained on maximal tolerated dose of established statin therapy (\\>4 weeks)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Colchicine 0.5 MG","Low dose daily colchicine",[9],[26],{"name":27,"affiliation":5,"role":28},"Nilesh Pareek, MA MBBS PhD","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Anne-Marie Murtagh","CONTACT","+44 02032999000","31285","qm.khpcto@kcl.ac.uk",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Michael McGarvey, MA MBBS MRCP","michael.mcgarvey@nhs.net",{"type":40,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[42],{"name":43,"class":6},"King's College London","100552164","phase-3-escalation-of-medical-therapy-following-multimodality-plaque-evaluation-in-high-risk-chronic-coronary-syndromes-100552164",false,"NCT06469528","ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes","ESCALATE","Inclusion Criteria:\n\n1. Ability to provide written informed consent\n2. Age 18 to 90 years old\n3. Male, or female of non-child-bearing potential\n4. Elevated clinical risk, as evidenced by ≥1 of:\n\n   * Previous spontaneous acute myocardial infarction (diagnosed according to the universal MI criteria) with or without persistent ST-segment elevation\n   * Previous stroke or intervention for peripheral arterial disease (i.e., evidence of atherosclerotic disease affecting \\>1 vascular bed)\n   * Established diagnosis of diabetes mellitus\n   * Systemic Coronary Risk Estimation 2 (SCORE2) or Systemic Coronary Risk Estimation 2 - Older Persons (SCORE2-OP) algorithm 10-year risk of fatal and non-fatal myocardial infarction or stroke \\>10%\n5. Documented evidence of coronary artery disease, with an angiographically moderate stenosis on invasive coronary angiography (30-80%)\n\n   \\- At least one non-flow limiting (FFR \\>0.80) moderate lesion with TCFA (minimum fibrous cap thickness of less than or equal to120µm and lipid arc \\>90°)\n6. History of prescribed statin therapy, at a stable dose, for \\>4 weeks\n7. Evidence of residual inflammation at baseline (i.e., high-sensitivity CRP ≥2)\n\nExclusion Criteria:\n\n1. Women who are pregnant, breast feeding, or of child-bearing potential\n2. Symptoms of unstable angina, characterised as: angina at rest; new onset of severe exertional angina (CCS grade III or higher for \\\u003C4 weeks); or distinct, sudden, intensification of previously stable angina\n3. Previous spontaneous acute myocardial infarction (diagnosed according to the universal MI criteria) with or without persistent ST-segment elevation \\\u003C4 weeks from recruitment\n4. Previous coronary artery bypass grafting\n5. Known chronic total occlusion of coronary artery\n6. Chronic kidney disease with eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m2 per MDRD formula or renal replacement therapy at baseline assessment\n7. Known active or recurrent hepatic disorder (including cirrhosis, hepatitis B and hepatitis C, or confirmed ALT\u002FAST levels \\> 3 times ULN or total bilirubin \\> 2 times ULN) at baseline assessment\n8. Symptoms of severe heart failure (systolic or diastolic) with New York Heart Association (NYHA) Functional Classification 3 or 4\n9. Moderate or severe valvular heart disease considered likely to require intervention\n10. History of blood dyscrasia including anaemia, thrombocytopenia, neutrophilia, leukopenia or other abnormality of blood count at baseline\n11. Peripheral neuritis, myositis or marked myo-sensitivity to statins\n12. A history of alcohol and\u002For substance abuse that could interfere with the conduct of the trial\n13. Patients with suspected or proven immunocompromised state, including:\n\n    1. those with evidence of Human Immunodeficiency Virus (HIV) infection; Patients on anti-retroviral therapy are excluded\n    2. those with any other medical condition which in the opinion of the investigator places the patient at unacceptable risk for participation in immunomodulatory therapy\n14. History of hypersensitivity to the study drug or its constituents\n15. Patients who have received an investigational drug or device within 30 days (inclusive) of baseline assessment, or who are expected to participate in any other investigational drug or device study during the conduct of this trial\n16. Any biologic drugs targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, tocilizumab)\n17. Established long-term pharmacotherapy with a strong CYP3A4 inhibitor or a P-glycoprotein inhibitor (P-gpi) (e.g., macrolide antibiotics, ciclosporin, ketoconazole, itraconazole, voriconazole, HIV protease inhibitors, verapamil, diltiazem and disulfiram)\n18. Contraindications to intravenous adenosine will exclude patients from adenosine induced hyperaemia\n19. Any life-threatening condition with life expectancy \\\u003C6 months that might prevent the patient from completing the study.","ALL","18 Years","90 Years",{"count":55,"type":56},50,"ESTIMATED","INTERVENTIONAL",[59],"PHASE3","ESCALATE will provide a thorough investigation of how anti-inflammatory therapy, with low-dose colchicine, affects patients with stable coronary artery disease. Using traditional clinical risk factors and multimodality intracoronary imaging, the investigators will identify patients with the greatest clinical risk.\n\nParticipants will undergo repeat multimodality intracoronary imaging assessment at 6 months to measure the impact once-daily low-dose colchicine therapy on the structure and function of coronary arteries.\n\nThis study will provide valuable insights into how anti-inflammatory therapies, such as colchicine, may improve outcomes in patients with coronary artery disease.",[62],"Coronary Artery Disease",[64],"Chronic coronary syndromes","NOT_YET_RECRUITING","2024-06-17",{"date":68,"type":69},"2024-06-21","ACTUAL",{"date":71,"type":56},"2024-06-24",{"date":73,"type":56},"2026-10-05",{"name":5,"class":6}]