Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT06078904
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Doses of Colchicine on hsCRP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage change in hsCRP', 'timeFrame': '4 weeks', 'description': 'The percentage change in hsCRP compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac and cerebrovascular event (MACCE)', 'timeFrame': '4 weeks', 'description': 'Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia'}, {'measure': 'Bleeding', 'timeFrame': '4 weeks', 'description': 'Bleeding defined according to Bleeding Academic Research Consortium'}, {'measure': 'Plasma inflammatory cytokines level', 'timeFrame': '4 weeks', 'description': 'Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc)'}, {'measure': 'Blood drug concentrations of different doses of colchicine', 'timeFrame': '4 weeks', 'description': 'Blood drug concentrations of different doses of colchicine'}, {'measure': 'Expression of inflammation-related proteins in peripheral blood mononuclear cells', 'timeFrame': '4 weeks', 'description': 'Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'pmid': '33769515', 'type': 'BACKGROUND', 'citation': 'Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115.'}, {'pmid': '37558377', 'type': 'BACKGROUND', 'citation': 'Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.'}]}, 'descriptionModule': {'briefSummary': 'Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular diseases on June, 2023. However, there is a lack of evidence for colchicine in East Asian population with coronary heart disease, and its effectiveness and safety need further exploration. Therefore, this study aims to use different doses of colchicine to treat patients with coronary heart disease after percutaneous coronary intervention, explore the effects of different doses of colchicine on hsCRP levels, and find the optimal dose of colchicine for treating coronary heart disease in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Volunteer to participate, understand and sign an informed consent form;\n2. Age ≥ 18 years old, regardless of gender;\n3. Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention;\n4. Complete all planned percutaneous coronary intervention during hospitalization;\n5. Patient must be treated according to national guidelines for standard treatment of coronary heart disease.\n\nExclusion Criteria:\n\n1. Known allergies to colchicine;\n2. Colchicine was taken within 10 days before randomization;\n3. Abnormal liver function test (alanine aminotransferase \\>3 times the upper limit of normal value);\n4. Abnormal renal function test (eGFR\\<30mL/min);\n5. Thrombocytopenia (platelet count \\<100 g/L);\n6. Uncontrolled infectious diseases;\n7. Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc;\n8. Pre-existing or plan for the administration of nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory drugs, or chemotherapeutic drugs;\n9. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;\n10. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.'}, 'identificationModule': {'nctId': 'NCT06078904', 'briefTitle': 'Different Doses of Colchicine on hsCRP', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'COLCRP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Colchicine 0.5 MG', 'description': 'Colchicine 0.5 MG, one pill a day, oral intake', 'interventionNames': ['Drug: Colchicine 0.5 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colchicine 0.375 MG', 'description': 'Colchicine 0.375 MG, one pill a day, oral intake', 'interventionNames': ['Drug: Colchicine 0.375 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colchicine 0.25 MG', 'description': 'Colchicine 0.25 MG, one pill a day, oral intake', 'interventionNames': ['Drug: Colchicine 0.25 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, one pill a day, oral intake', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Colchicine 0.5 MG', 'type': 'DRUG', 'description': 'Colchicine 0.5 MG, one pill a day, oral intake', 'armGroupLabels': ['Colchicine 0.5 MG']}, {'name': 'Colchicine 0.375 MG', 'type': 'DRUG', 'description': 'Colchicine 0.375 MG, one pill a day, oral intake', 'armGroupLabels': ['Colchicine 0.375 MG']}, {'name': 'Colchicine 0.25 MG', 'type': 'DRUG', 'description': 'Colchicine 0.25 MG, one pill a day, oral intake', 'armGroupLabels': ['Colchicine 0.25 MG']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, one pill a day, oral intake', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director in the department of cardiology', 'investigatorFullName': 'Xiang Cheng', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}