[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523074":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":52,"centralContacts":57,"locations":66,"responsibleParty":112,"collaborators":33,"id":115,"slug":33,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":33,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":33,"enrollmentInfo":123,"targetDuration":33,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":69,"whyStopped":33,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"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",[67,84,94,104],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Beijing Anzhen Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","10000","China",{"type":75,"coordinates":76},"Point",[77,78],116.39723,39.9075,{"lat":78,"lon":77},[81],{"name":82,"role":59,"phone":83,"phoneExt":33,"email":61},"Haiyan Qian, MD, PhD","+86 17200376143",{"facility":85,"status":86,"city":70,"state":71,"zip":72,"country":73,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Beijing Friendship Hospital","NOT_YET_RECRUITING",{"type":75,"coordinates":88},[77,78],{"lat":78,"lon":77},[91],{"name":92,"role":59,"phone":33,"phoneExt":33,"email":93},"Ruifeng Liu, MD","fengziliu04@163.com",{"facility":95,"status":69,"city":70,"state":71,"zip":72,"country":73,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Beijing Luhe Hospital",{"type":75,"coordinates":97},[77,78],{"lat":78,"lon":77},[100],{"name":101,"role":59,"phone":102,"phoneExt":33,"email":103},"Ming Guo, MD","+86 15810975298","guoming2004_1999@Sina.com",{"facility":105,"status":69,"city":70,"state":71,"zip":33,"country":73,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Fuwai Hospital",{"type":75,"coordinates":107},[77,78],{"lat":78,"lon":77},[110],{"name":82,"role":59,"phone":111,"phoneExt":33,"email":61},"+86 13811386143",{"type":56,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Qian Haiyan","Director，Clinical Professor","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":124,"type":125},252,"ESTIMATED","INTERVENTIONAL",[128],"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).",[131],"In-stent Restenosis",[133,131,30,35],"Anti-inflammatory therapy","2025-08-05",{"date":136,"type":137},"2025-08-08","ACTUAL",{"date":139,"type":137},"2023-10-30",{"date":141,"type":125},"2027-10-29",{"name":5,"class":6},4]