Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-06 @ 9:58 AM
Study NCT ID:
NCT06572267
Status:
RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C434107', 'term': 'mepolizumab'}, {'id': 'D044382', 'term': 'Population Groups'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-24', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of high PVAT attenuation coefficient among non-target lesion(s)', 'timeFrame': '6 months', 'description': 'Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA'}], 'secondaryOutcomes': [{'measure': 'Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up', 'timeFrame': '6 months'}, {'measure': 'Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up', 'timeFrame': '6 months'}, {'measure': 'Changes in inflammatory biomarkers from baseline to follow-up', 'timeFrame': '6 months', 'description': 'Biomarkers including hs-CRP, IL-1, IL-2, IL-4, IL-6, INF-α, IL-8, IL-10, IL-12p70, IL-17, IL-1β, TNF-α and IFN-γ'}, {'measure': 'Device-oriented clinical endpoint (DoCE)', 'timeFrame': '1 month and 6 months', 'description': 'Device-oriented clinical endpoint is a composite endpoint including cardiac death, target vessel infarction, and clinically driven target lesion revascularization'}, {'measure': 'Cardiac death', 'timeFrame': '1 month and 6 months', 'description': 'The individual component of the DoCE'}, {'measure': 'Target vessel infarction', 'timeFrame': '1 month and 6 months', 'description': 'The individual component of the DoCE'}, {'measure': 'Clinically driven target lesion revascularization', 'timeFrame': '1 month and 6 months', 'description': 'The individual component of the DoCE'}, {'measure': 'Patient-oriented composite endpoint (PoCE)', 'timeFrame': '1 month and 6 months', 'description': 'Patient-oriented composite endpoint is a composite endpoint including all-cause death, any stroke, any myocardial infarctions, and any revascularization'}, {'measure': 'All-cause death', 'timeFrame': '1 month and 6 months', 'description': 'The individual component of the PoCE'}, {'measure': 'Any stroke', 'timeFrame': '1 month and 6 months', 'description': 'The individual component of the PoCE'}, {'measure': 'Any myocardial infarction', 'timeFrame': '1 month and 6 months', 'description': 'The individual component of the PoCE'}, {'measure': 'Any revascularization', 'timeFrame': '1 month and 6 months', 'description': 'The individual component of the PoCE'}, {'measure': 'Changes in gene expression of peripheral blood mononuclear cells', 'timeFrame': '6 months'}, {'measure': 'Any adverse events', 'timeFrame': '1, 2, 3, 4, 5, and 6 months', 'description': 'All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meplazumab', 'coronary artery disease', 'inflammation', 'lipid deposition'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25824988', 'type': 'BACKGROUND', 'citation': 'Sturhan H, Ungern-Sternberg SN, Langer H, Gawaz M, Geisler T, May AE, Seizer P. Regulation of EMMPRIN (CD147) on monocyte subsets in patients with symptomatic coronary artery disease. Thromb Res. 2015 Jun;135(6):1160-4. doi: 10.1016/j.thromres.2015.03.022. Epub 2015 Mar 20.'}, {'pmid': '38166463', 'type': 'BACKGROUND', 'citation': 'Lv JJ, Wang H, Zhang C, Zhang TJ, Wei HL, Liu ZK, Ma YH, Yang Z, He Q, Wang LJ, Duan LL, Chen ZN, Bian H. CD147 Sparks Atherosclerosis by Driving M1 Phenotype and Impairing Efferocytosis. Circ Res. 2024 Jan 19;134(2):165-185. doi: 10.1161/CIRCRESAHA.123.323223. Epub 2024 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with chronic coronary syndrome\n2. Non-target lesions with stenosis ≥50% by visual assessment\n3. Angina symptoms manageable via antianginal medication\n4. High attenuation coefficient (≥-70.1 HU) of perivascular adipose tissue (PVAT) around non-target lesions as assessed by coronary CT angiography (CCTA)\n5. Patients who are able to complete the follow-up and compliant to the prescribed medication\n\nExclusion Criteria:\n\n1. Under the age of 18\n2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint\n3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)\n4. Concurrent medical condition with a life expectancy of less than 3 years\n5. Haemodynamical unstable\n6. Known contraindications to medications such as test drug and its components, heparin, or contrast\n7. The following criteria are met for any of the laboratory test indicators at the time of screening ①ALT/AST \\>3ULN；②TBil ≥2ULN；③WBC\\>2ULN；④NEUT\\<0.5×109 /L；⑤PLT\\<30×109 /L；⑥eGFR \\&lt;60 mL/min/1.73 m2（CKD-EPI formula）\n8. Suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate'}, 'identificationModule': {'nctId': 'NCT06572267', 'acronym': 'REC-SAFECAD', 'briefTitle': 'Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial', 'orgStudyIdInfo': {'id': 'KY20242170-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mepolizumab low dose group', 'description': 'Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.05 mg/kg, monthly.\n\nMeperizumab was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.', 'interventionNames': ['Drug: Mepolizumab low dose group']}, {'type': 'EXPERIMENTAL', 'label': 'Mepolizumab middle dose group', 'description': 'Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.1 mg/kg, monthly.\n\nMeperizumab was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.', 'interventionNames': ['Drug: Mepolizumab middle dose group']}, {'type': 'EXPERIMENTAL', 'label': 'Mepolizumab high dose group', 'description': 'Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.2 mg/kg, monthly.\n\nMeperizumab was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.', 'interventionNames': ['Drug: Mepolizumab high dose group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Saline, 100 ml, intravenous infusion', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Mepolizumab low dose group', 'type': 'DRUG', 'description': 'Meperizumab (0.05 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.', 'armGroupLabels': ['Mepolizumab low dose group']}, {'name': 'Mepolizumab middle dose group', 'type': 'DRUG', 'description': 'Meperizumab (0.1 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.', 'armGroupLabels': ['Mepolizumab middle dose group']}, {'name': 'Mepolizumab high dose group', 'type': 'DRUG', 'description': 'Meperizumab (0.2 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.', 'armGroupLabels': ['Mepolizumab high dose group']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chao Gao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'woshigaochao@gmail.com', 'phone': '86-18629551066'}], 'facility': 'Ling Tao', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Chao Gao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'woshigaochao@gmail.com', 'phone': '18629551066'}], 'overallOfficials': [{'name': 'Ling Tao, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital'}, {'name': 'Ping Zhu, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital'}, {'name': 'Chao Gao, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Cardiology', 'investigatorFullName': 'Ling Tao, MD, PhD', 'investigatorAffiliation': 'Xijing Hospital'}}}}