[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638823":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":42,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":26,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"The Third Affiliated hospital of Zhejiang Chinese Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Participants in this arm receive standard medical therapy for coronary heart disease according to current guidelines, including dual antiplatelet therapy , statins, beta-blockers, ACEI\u002FARB, and other medications as clinically indicated. In addition, they take Qidan Xiaoke Granules orally, one sachet twice daily for 12 consecutive weeks. The granules are dissolved in warm water before administration. The intervention period is 12 weeks, with follow-up assessments at 24, 36, and 48 weeks after baseline. The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 48 weeks.",[13],"Drug: Qidan Xiaoke Granules + Standard Medical Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Participants in this arm receive the same standard medical therapy as the experimental group. In addition, they take a placebo matching the Qidan Xiaoke Granules in appearance, taste, odor, and packaging at the same dosage regimen: one sachet twice daily for 12 weeks. The placebo has no pharmacological activity related to the investigational product. The treatment and follow-up schedule are identical to the experimental group.",[19],"Drug: Placebo + Standard Medical Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Qidan Xiaoke Granules + Standard Medical Therapy","Participants in this arm receive standard medical therapy for coronary heart disease according to current guidelines, including dual antiplatelet therapy, statins, beta-blockers, ACEI\u002FARB, and other medications as clinically indicated. In addition, they take Qidan Xiaoke Granules orally, one sachet twice daily for 12 consecutive weeks. The granules are dissolved in warm water before administration. The intervention period is 12 weeks, with follow-up assessments at 24, 36, and 48 weeks after baseline. The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 48 weeks.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Placebo + Standard Medical Therapy",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Liu Qiang, PhD","CONTACT","+86 13588121905","19981011@zcmu.edu.cn",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Liu Qiang","Principal Investigator","100638823","phase-3-clinical-study-of-chinese-herbal-compound-qidan-xiaoke-granules-in-patients-after-coronary-revascularization-100638823",false,"NCT07616544","Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization","Inclusion Criteria:\n\n1. Age: 18-80 years old;\n2. no gender limitation;\n3. Meets the diagnostic criteria for coronary heart disease;\n4. Accepts effective PCI procedure;\n5. Voluntarily participates and signs a written informed consent form.\n\nExclusion Criteria:\n\n1. Severe hepatic and\u002For renal insufficiency\n2. Severe electrolyte disorders\n3. Severe hematological diseases or malignant tumors\n4. Pregnant or breastfeeding women\n5. Patients with mental illness\n6. Cognitive impairment (e.g., dementia, post-stroke cognitive impairment) leading to inability to communicate normally\n7. Planning to undergo another revascularization surgery in the near future\n8. Other severe cardiovascular diseases (e.g., uncontrolled hypertension, angina pectoris, rapid arrhythmias, high-degree or complete atrioventricular block without a pacemaker implanted, acute severe aortic stenosis, decompensated heart failure (NYHA Class IV), deep vein thrombosis, obstructive hypertrophic cardiomyopathy, acute pericarditis or myocarditis, acute endocarditis, acute aortic dissection, etc.)\n9. Acute pulmonary embolism and chronic lung diseases with dyspnea symptoms (occurring at rest or with minimal exertion)\n10. Explicit exclusion criteria (bleeding history within 1 month, active bleeding, bleeding tendency, currently using anticoagulants)\n11. Participants in other interventional clinical trials within the past month\n12. Allergy to known components of the investigational drug (Qidan Xiaohe Granules)\n13. Other conditions deemed unsuitable for participation in the trial by the investigator","ALL","18 Years","80 Years",{"count":50,"type":51},164,"ESTIMATED","INTERVENTIONAL",[54],"PHASE3","1. Evaluate the efficacy and safety of Qidan Xiaohe granules in patients after coronary revascularization surgery;\n2. Develop a traditional Chinese medicine rehabilitation treatment plan and evaluation system for the use of Qidan Xiaohe granules after coronary revascularization surgery;\n3. Demonstrate the advantages of traditional Chinese medicine rehabilitation treatment in the postoperative management of coronary revascularization surgery and provide high-level evidence-based medical evidence for the development of traditional Chinese medicine rehabilitation treatment plans.",[57,58,59],"Percutaneous Coronary Intervention","Myocardial Revascularization","Coronary Artery Disease","NOT_YET_RECRUITING","2026-05-27",{"date":63,"type":64},"2026-06-01","ACTUAL",{"date":66,"type":51},"2026-07-01",{"date":68,"type":51},"2028-12-31",{"name":38,"class":6}]