Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
Study NCT ID:
NCT05105750
Status:
UNKNOWN
Last Update Posted:
2022-01-19
First Post:
2021-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
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': 'D001241', 'term': 'Aspirin'}, {'id': 'C020371', 'term': 'indobufen'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MPA', 'timeFrame': 'Within 24 hours after one month of medication', 'description': 'Maximum platelet aggregation induced by arachidonic acid'}, {'measure': 'TXB2', 'timeFrame': 'Within 1 month after one month of medication', 'description': 'Plasma thromboxaneB2'}, {'measure': '11-dh-TXB2', 'timeFrame': 'Within 1 month after one month of medication', 'description': 'Urine 11-dehydro thromboxaneB2'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Within 1 month after the first medication', 'description': 'Monitor the bleeding events of subjects during the trial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Light Transmittance Aggregometry', 'Indobufen', 'Aspirin', 'Plasma Thromboxane', 'Urine 11-dehydro thromboxane'], 'conditions': ['Coronary Atherosclerosis']}, 'descriptionModule': {'briefSummary': "In addition, studies have found that indobufen can inhibit coagulation function in rats. Compared with aspirin, the duration of antiplatelet efficacy of indobufen was shorter, and the platelet function recovered completely 24 hours after drug withdrawal. However, there are few studies on the antiplatelet efficacy of indobufen. The investigators' previous study found that the inhibitory effect of indobufen 100 mg Bid on COX system in atherosclerosis or healthy volunteers was equivalent to that of aspirin 100 mg QD, but the inhibitory effect on platelet COX-1 channel was significantly weaker than that of aspirin 100 mg QD. In view of this, this study intends to investigate the antiplatelet effect of indobufen 200 mg Bid in patients with coronary atherosclerosis by comparing it with conventional-dose aspirin 100 mg QD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of coronary atherosclerosis without indications for stent implantation.\n2. Age ≥ 18 years, ≤ 65 years\n3. Sign informed consent\n\nExclusion Criteria:\n\n1. A history of asthma or allergic constitution or known allergy to indobufen or aspirin.\n2. High risk of bleeding (low hemoglobin 10g / L, history of peptic ulcer disease, fecal occult blood positive or known active bleeding, history of cerebral hemorrhage within 6 months, history of fundus hemorrhage, etc).\n3. Creatinine was 1.2 times higher than the upper limit of normal value and ALT was 1.2 times higher than the normal value.\n4. History of smoking and alcoholism.\n5. History of diabetes.\n6. Pregnancy and lactation women.\n7. Nonsteroidal anti-inflammatory or other antithrombotic drugs other than indobufen are required.\n8. Any other reason may affect the results of this study.'}, 'identificationModule': {'nctId': 'NCT05105750', 'briefTitle': 'A Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Comparative Study on Antiplatelet Efficacy of Indobufen and Aspirin in Patients With Coronary Atherosclerosis', 'orgStudyIdInfo': {'id': '016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aspirin 100 mg/d therapy', 'interventionNames': ['Drug: aspirin 100 mg/d']}, {'type': 'EXPERIMENTAL', 'label': 'indobufen 200 mg bid therapy', 'interventionNames': ['Drug: indobufen 200 mg bid']}], 'interventions': [{'name': 'aspirin 100 mg/d', 'type': 'DRUG', 'description': '100mg aspirin for at least 3 days followed by aspirin 100 mg/d', 'armGroupLabels': ['aspirin 100 mg/d therapy']}, {'name': 'indobufen 200 mg bid', 'type': 'DRUG', 'description': '100mg aspirin for at least 3 days followed by indobufen 200 mg bid', 'armGroupLabels': ['indobufen 200 mg bid therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fuming Zhang, M.D.', 'role': 'CONTACT', 'email': 'jsphkj@163.com', 'phone': '+86-25-83718836', 'phoneExt': '6360'}, {'name': 'Yi Chai, M.D.', 'role': 'CONTACT', 'email': 'jsphkj@163.com', 'phone': '+86-25-83718836', 'phoneExt': '6360'}], 'facility': 'First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Li Chunjian, Ph.D', 'role': 'CONTACT', 'email': 'lijay@njmu.edu.cn', 'phone': '86-25-83718836'}, {'name': 'Ye Zekang', 'role': 'CONTACT', 'email': 'yezekang@njmu.edu.cn', 'phone': '17816872076'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr., MD, Ph.D, Director of CCU Ward', 'investigatorFullName': 'Chunjian Li', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}