Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-01 @ 9:37 AM
Study NCT ID:
NCT03230851
Status:
UNKNOWN
Last Update Posted:
2017-07-31
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-09-09', 'releaseDate': '2020-08-20'}], 'estimatedResultsFirstSubmitDate': '2020-08-20'}}, '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': 'D013812', 'term': 'Therapeutics'}, {'id': 'C020371', 'term': 'indobufen'}], '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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-07-24', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'platelet aggregation', 'timeFrame': '2 hours', 'description': 'Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).'}, {'measure': 'plasma thromboxaneB2', 'timeFrame': '3montshs', 'description': 'The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)'}, {'measure': 'urine 11-dehydro thromboxaneB2', 'timeFrame': '3 months', 'description': 'The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Light Transmittance Aggregometry', 'Indobufen', 'Aspirin', 'Plasma Thromboxane', 'Urine 11-dehydro thromboxane'], 'conditions': ['Coronary Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach Intestinal reactions, small bleeding events are recorded.', 'detailedDescription': 'A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (\\> 160 / 100mmHg),hemoglobin concentration \\<100g /L, hemorrhagic disease or a history of bleeding tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor, active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate, plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1month,6months and1 year. The stomach Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of coronary atherosclerosis without indications for stent implantation .\n\nPatient aged \\>18 years and ≤75years. Must be able to swallow tablets\n\nExclusion Criteria:\n\nAspirin resistance; uncontrolled hypertension (\\> 160 / 100mmHg); hemoglobin \\<100g / L; hemorrhagic disease or bleeding tendency history; taking other non-steroidal drugs; severe liver disease history; malignant neoplasms; active gastric mucosa bleeding; PCI history; coronary artery bypass surgery; cardiac function grade Ⅳ.'}, 'identificationModule': {'nctId': 'NCT03230851', 'briefTitle': 'the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy', 'orgStudyIdInfo': {'id': '006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aspirin 100mg/d therapy', 'description': 'Group1: aspirin 100 mg/d;', 'interventionNames': ['Drug: aspirin 100mg/d therapy']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin 100mg/2d therapy', 'description': 'Group2: aspirin ;', 'interventionNames': ['Drug: aspirin 100mg/2d therapy']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin 100mg/3d therapy', 'description': 'Groups3: aspirin ;', 'interventionNames': ['Drug: aspirin 100mg/3d therapy']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin 50mg bid therapy', 'description': 'Groups4: morning 50mg evening 50mg;', 'interventionNames': ['Drug: aspirin 50mg bid therapy']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin 75mg/d therapy', 'description': 'Group5: aspirin 75mg / d;', 'interventionNames': ['Drug: aspirin 75mg/d therapy']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin 50mg/d therapy', 'description': 'Group6: aspirin 50mg / d;', 'interventionNames': ['Drug: aspirin 50mg/d therapy']}, {'type': 'EXPERIMENTAL', 'label': 'indobufen 100mg bid therapy', 'description': 'Group7: 100mg bid', 'interventionNames': ['Drug: indobufen 100mg bid therapy']}], 'interventions': [{'name': 'aspirin 100mg/d therapy', 'type': 'DRUG', 'description': '100mg aspirin for at least 5 days followed by aspirin 100mg/d', 'armGroupLabels': ['aspirin 100mg/d therapy']}, {'name': 'aspirin 100mg/2d therapy', 'type': 'DRUG', 'description': '100mg aspirin for at least 5 days followed by aspirin 100mg/2d', 'armGroupLabels': ['aspirin 100mg/2d therapy']}, {'name': 'aspirin 100mg/3d therapy', 'type': 'DRUG', 'description': '100mg aspirin for at least 5 days followed by aspirin 100mg/3d', 'armGroupLabels': ['aspirin 100mg/3d therapy']}, {'name': 'aspirin 50mg bid therapy', 'type': 'DRUG', 'description': '100mg aspirin for at least 5 days followed by aspirin 50mg bid', 'armGroupLabels': ['aspirin 50mg bid therapy']}, {'name': 'aspirin 75mg/d therapy', 'type': 'DRUG', 'description': '100mg aspirin for at least 5 days followed by aspirin 75mg/d', 'armGroupLabels': ['aspirin 75mg/d therapy']}, {'name': 'aspirin 50mg/d therapy', 'type': 'DRUG', 'description': '100mg aspirin for at least 5 days followed by aspirin 50mg/d', 'armGroupLabels': ['aspirin 50mg/d therapy']}, {'name': 'indobufen 100mg bid therapy', 'type': 'DRUG', 'description': '100mg aspirin for at least 5 days followed by indobufen 100mg bid', 'armGroupLabels': ['indobufen 100mg bid therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', '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', 'phoneExt': '6018'}, {'name': 'Mei Lianlian', 'role': 'CONTACT', 'email': 'Maylianlian1989@163.com', 'phone': '17766092046'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Chunjian Li', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-20', 'type': 'RELEASE'}, {'date': '2020-09-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chunjian Li, professor, The First Affiliated Hospital with Nanjing Medical University'}}}}