[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628491":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":25,"collaborators":18,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":31,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":18,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":18},{"fullName":5,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Colchicine group","EXPERIMENTAL","Drug: Colchicine Dosage form: Tablets Dosage: 0.5 mg Frequency: Once daily Duration: From enrollment to the one-month follow-up visit is completed.",[13],"Drug: colchicine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","No Intervention",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","colchicine","Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed",[9],{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Xueyan Zhao","Chief physician, M.D., FACC, FESC, Doctoral supervisor","100628491","phase-4-proteomic-and-inflammatory-omics-changes-with-colchicine-therapy-in-coronary-heart-disease-100628491",false,"NCT07462325","Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease","Proteomic Changes Before and After Colchicine Treatment in hsCRP-Elevated Coronary Heart Disease Patients: A Randomized Controlled Open-Label Study","PIC-CHD","Inclusion Criteria:\n\n* Diagnosis \\& Treatment: Have symptoms or objective evidence of myocardial ischemia and have undergone successful Percutaneous Coronary Intervention (PCI).\n\nInflammation Status: Have a plasma high-sensitivity C-reactive protein (hs-CRP) level ≥ 2 mg\u002FL at the time of screening.\n\nBackground Therapy: Be on guideline-directed standard medical therapy for coronary heart disease, tailored to their individual clinical condition.\n\nInformed Consent: The participant or their legally authorized representative must be capable of understanding the study and must provide written informed consent.\n\nExclusion Criteria:\n\n* Recent Cardiac Event: Acute Myocardial Infarction within the past 1 month. Drug Intolerance: Known allergy or intolerance to colchicine.\n\nHematologic Abnormalities:\n\nPlatelet count \\\u003C 110 × 10⁹\u002FL White blood cell count \\\u003C 4.0 × 10⁹\u002FL Hemoglobin level \\\u003C 115 g\u002FL\n\nRenal Impairment:\n\nEstimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m² (calculated using the MDRD formula), OR Serum creatinine level \\> 2 times the upper limit of normal (ULN).\n\nHepatic Impairment:\n\nSevere liver cirrhosis, biliary cirrhosis, or cholestasis, OR Liver enzyme (transaminase) levels \\> 3 times the ULN. Bone Marrow Disorder: Known history of bone marrow hypoplasia.\n\nSevere Cardiac Conditions:\n\nNew York Heart Association (NYHA) Class III-IV heart failure, OR Left Ventricular Ejection Fraction (LVEF) \\\u003C 35%, OR Moderate or severe valvular heart disease requiring intervention. Recent Cerebrovascular Event\u002FInstability: Stroke within the past 3 months, or current cardiogenic shock or hemodynamic instability.\n\nActive Malignancy: Concurrent active tumor or cancer. Chronic Pulmonary Disease: Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung diseases.\n\nInflammatory Bowel Disease (IBD) or Chronic Diarrhea: e.g., Crohn's disease, ulcerative colitis.\n\nUncontrolled Comorbidities: Any other uncontrolled disease or condition that, in the investigator's judgment, would place the participant at undue risk by participating in the study.\n\nActive Systemic Inflammation\u002FInfection: Presence of systemic inflammation or acute infection at the time of enrollment.\n\nConcurrent Steroid Use: Current use or planned initiation of systemic corticosteroid therapy during the study period (excluding topical or inhaled steroids).\n\nPregnancy\u002FBreastfeeding: Women who are pregnant, planning to become pregnant, or breastfeeding.\n\nConcurrent Trial Participation: Participation in another interventional clinical trial within the past 3 months that may interfere with the outcomes of this study.","ALL","18 Years","85 Years",{"count":41,"type":42},176,"ESTIMATED","INTERVENTIONAL",[45],"PHASE4","The goal of this exploratory clinical trial is to investigate the proteomic changes induced by low-dose colchicine anti-inflammatory therapy in coronary heart disease (CHD) patients, with the aim of identifying novel biomarkers and therapeutic targets.\n\nThe main questions it aims to answer are:\n\n* Whether short-term colchicine treatment induces significant changes in the plasma proteomic profile of post-PCI CHD patients with residual inflammation.\n* Which specific proteins or pathways are dynamically modulated by colchicine, indicating potential mechanisms of action and drug targets.\n* How the proteomic expression profiles differ between patients treated with colchicine and matched controls after one month.\n\nParticipants, recruited based on a prior RCT framework, will be post-PCI CHD patients with elevated inflammation (hs-CRP ≥ 2 mg\u002FL). A total of 176 participants will be enrolled: 88 in the trial group (colchicine 0.5 mg\u002Fday) and 88 in the matched control group (no intervention). All participants will complete a one-month follow-up. Peripheral blood samples will be collected at baseline and at the one-month visit for high-throughput proteomic analysis using Olink technology.",[48],"Coronary Heart Disease (CHD)",[50,51,52,53,54,55,56,57],"Colchicine","Proteomics","Biomarkers","Olink","Anti-Inflammatory Therapy","Randomized Controlled Trial (RCT)","High-Throughput Screening","Precision Medicine","NOT_YET_RECRUITING","2026-03-17",{"date":61,"type":62},"2026-03-19","ACTUAL",{"date":64,"type":42},"2026-03-01",{"date":66,"type":42},"2027-03-31",{"name":5,"class":6}]