[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523074":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":52,"centralContacts":57,"locations":66,"responsibleParty":113,"collaborators":33,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":33,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":33,"enrollmentInfo":125,"targetDuration":33,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":69,"whyStopped":33,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Fu Wai Hospital, Beijing, China","OTHER",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"control group","ACTIVE_COMPARATOR","DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary)",[13,14,15],"Drug: Aspirin","Drug: P2Y12 Receptor Antagonist","Drug: Lipid-lowering drug",{"label":17,"type":18,"description":19,"interventionNames":20},"Colchicine group","EXPERIMENTAL","DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally)",[21,13,14,15],"Drug: Colchicine",{"label":23,"type":18,"description":24,"interventionNames":25},"Prednisone group","DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg\u002Fkg QD, orally)",[26,13,14,15],"Drug: Prednisone",[28,34,38,44,48],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Colchicine","Add 0.5mg QD orally and start using it within 48 hours after intervention.",[17],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Prednisone","0.5mg\u002Fkg QD orally and the dosage was reduced at a rate of 5mg\u002Fd per month until 5-10mg\u002Fd, maintained for 1 year after PCI.",[23],{"type":29,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Aspirin","Patients who have re-implanted DES should receive aspirin for at least 1 year after intervention; Patients who have underwent DEB expansion should apply aspirin for at least 3 months after intervention.",[17,23,9],[43],"Acetylsalicylic Acid",{"type":29,"name":45,"description":46,"armGroupLabels":47,"otherNames":33},"P2Y12 Receptor Antagonist","Patients who have re-implanted DES should receive 1 P2Y12 receptor antagonist for at least 1 year after intervention; Patients who have underwent DEB expansion should apply the P2Y12 receptor antagonist for at least 3 months after intervention.",[17,23,9],{"type":29,"name":49,"description":50,"armGroupLabels":51,"otherNames":33},"Lipid-lowering drug","Formulate the lipid-lowering drug regimen with LDL-C\\\u003C1.4mmol\u002FL as the target on the basis of moderate intensity or above statins.",[17,23,9],[53],{"name":54,"affiliation":55,"role":56},"Haiyan Qian","Fuwai Hospital, Beijing, China","PRINCIPAL_INVESTIGATOR",[58,62],{"name":54,"role":59,"phone":60,"phoneExt":33,"email":61},"CONTACT","+8613811386143","ahqhy712@163.com",{"name":63,"role":59,"phone":64,"phoneExt":33,"email":65},"Zhiyao Wei","+8615521192379","weizhiyaoyx@163.com",[67,85,95,105],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Beijing Anzhen Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","10000","China","CN",{"type":76,"coordinates":77},"Point",[78,79],116.39723,39.9075,{"lat":79,"lon":78},[82],{"name":83,"role":59,"phone":84,"phoneExt":33,"email":61},"Haiyan Qian, MD, PhD","+86 17200376143",{"facility":86,"status":87,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Beijing Friendship Hospital","NOT_YET_RECRUITING",{"type":76,"coordinates":89},[78,79],{"lat":79,"lon":78},[92],{"name":93,"role":59,"phone":33,"phoneExt":33,"email":94},"Ruifeng Liu, MD","fengziliu04@163.com",{"facility":96,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Beijing Luhe Hospital",{"type":76,"coordinates":98},[78,79],{"lat":79,"lon":78},[101],{"name":102,"role":59,"phone":103,"phoneExt":33,"email":104},"Ming Guo, MD","+86 15810975298","guoming2004_1999@Sina.com",{"facility":106,"status":69,"city":70,"state":71,"zip":33,"country":73,"countryCode":74,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Fuwai Hospital",{"type":76,"coordinates":108},[78,79],{"lat":79,"lon":78},[111],{"name":83,"role":59,"phone":112,"phoneExt":33,"email":61},"+86 13811386143",{"type":56,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Qian Haiyan","Director，Clinical Professor","100523074","phase-4-anti-inflammatory-therapy-for-recurrent-in-stent-restenosis-100523074",false,"NCT06090890","Anti-inflammatory Therapy for Recurrent In-stent Restenosis","Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial","Inclusion Criteria:\n\n1. CAD patients over 18 years old;\n2. At least one coronary artery lesion meets the RISR criteria: target lesion ≥ 2 ISRs (stenosis of lumen diameter within the stent segment and within 5mm near and far of the stent ≥ 50%);\n3. Intended intervention treatment for RISR lesions;\n4. Acceptable for standard secondary prevention drug therapy for coronary heart disease, including dual antiplatelet therapy (DAPT) and statins;\n5. Willing to participate in the trial and complete follow-up, signing an informed consent form approved by the ethics committee\n\nExclusion Criteria:\n\n1. The previous interventional treatment situation is unknown;\n2. The mechanism of intracavitary imaging to clarify ISR is operator-related (poor stent adhesion, incomplete dilation, and stent fracture);\n3. Clearly diagnose vascular inflammatory diseases or connective tissue diseases (including arteritis, Behcet's disease, systemic lupus erythematosus, etc.) involving the coronary artery;\n4. Immunosuppressive drugs, including glucocorticoids, have been used in the past 30 days;\n5. There are contraindications to the use of prednisone or colchicine, including: serious infectious diseases, including active infection, hepatitis B, hepatitis C or AIDS patients; Hematological diseases, such as thrombocytopenia, severe anemia, leukemia, etc; Uncontrolled diabetes; Severe liver and kidney function damage; Active peptic ulcer or gastrointestinal bleeding; Severe osteoporosis (with previous pathological fractures); Inflammatory bowel disease or chronic diarrhea;\n6. A history of malignant tumors within 3 years;\n7. Cognitive impairment;\n8. Not willing to participate or follow up","ALL","18 Years",{"count":126,"type":127},252,"ESTIMATED","INTERVENTIONAL",[130],"PHASE4","This study is aimed at making a comparison of the safety and efficacy of standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from recurrent In-stent restenosis (RISR).",[133],"In-stent Restenosis",[135,133,30,35],"Anti-inflammatory therapy","2025-08-05",{"date":138,"type":139},"2025-08-08","ACTUAL",{"date":141,"type":139},"2023-10-30",{"date":143,"type":127},"2027-10-29",{"name":5,"class":6},4]