Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03792035
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2018-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C513941', 'term': 'tongxinluo'}]}}, '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': 'ESTIMATED', 'count': 3796}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2018-12-03', 'studyFirstSubmitQcDate': '2019-01-01', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total white cell count', 'timeFrame': '7 days, 1 month, 6 months and 1 year after medication', 'description': 'Normal value: 4-10, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.'}, {'measure': 'Red blood cell', 'timeFrame': '7 days, 1 month, 6 months and 1 year after medication', 'description': 'Normal value: 3.5-5, unit: 1012/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.'}, {'measure': 'Hemoglobin', 'timeFrame': '7 days, 1 month, 6 months and 1 year after medication', 'description': 'Normal value: 110-150, unit: g/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.'}, {'measure': 'Blood platelet count', 'timeFrame': '7 days, 1 month, 6 months and 1 year after medication', 'description': 'Normal value: 100-300, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.'}], 'primaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '30-day', 'description': '30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)'}], 'secondaryOutcomes': [{'measure': 'Revascularization', 'timeFrame': '30-day', 'description': 'Incidence of revascularization of the primary endpoints'}, {'measure': 'Cerebral stroke', 'timeFrame': '30-day', 'description': 'Incidence of cerebral stroke of the primary endpoints'}, {'measure': 'STEMI', 'timeFrame': '30-day', 'description': '30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.'}, {'measure': 'The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V', 'timeFrame': '30-day', 'description': 'The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V at 30-day between 0-30%.'}, {'measure': 'MACCE', 'timeFrame': '1 year', 'description': '1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event.'}, {'measure': 'In-stent restenosis', 'timeFrame': '1 year', 'description': '1-year incidence of In-stent restenosis'}, {'measure': 'All-cause mortality rate at 1 year', 'timeFrame': '1 year', 'description': 'Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.'}, {'measure': 'Myocardial reperfusion and no-reflow', 'timeFrame': '2 hours, 24 hours and 7 days', 'description': 'Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '37874574', 'type': 'DERIVED', 'citation': 'Yang Y, Li X, Chen G, Xian Y, Zhang H, Wu Y, Yang Y, Wu J, Wang C, He S, Wang Z, Wang Y, Wang Z, Liu H, Wang X, Zhang M, Zhang J, Li J, An T, Guan H, Li L, Shang M, Yao C, Han Y, Zhang B, Gao R, Peterson ED; CTS-AMI Investigators. Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial. JAMA. 2023 Oct 24;330(16):1534-1545. doi: 10.1001/jama.2023.19524.'}]}, 'descriptionModule': {'briefSummary': 'To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\\>18 years;\n2. Within 24 hours of infarctional chest pain onset;\n3. ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB);\n4. Voluntary participation in the study with consent forms signed.\n\nExclusion Criteria:\n\n1. Critically illness due to STEMI;\n2. Long-term (\\>20 min) cardio-pulmonary resuscitation (CPR);\n3. Suspected aortic dissection or acute pulmonary embolism;\n4. Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls.\n5. Serious cardiogenic shock and do not responding to hypertensive agents;\n6. Uncontrolled acute left heart failure or pulmonary edema;\n7. Malignant arrhythmias uncontrolled by anti-arrhythmia agents;\n8. Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month;\n9. Presence of active hemorrhage at any part of the body (including menstruation);\n10. Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders;\n11. Current usage of anticoagulants (such as Warfarin or new anticoagulants);\n12. . Serious hepatorenal dysfunction \\[ATL≥5 ULN (upper limit of normal), Cr\\>134μmol/L (2mg%) or eGFR\\<45ml/min/1.73m2\\];\n13. Serious chronic obstructive pulmonary disease (COPD) or respiratory failure;\n14. . Severe infection:\n15. . Very weak or frailty;\n16. . Neuropsychiatric system diseases;\n17. . Malignancies;\n18. . Other pathophysiological conditions with expected survival time \\<1 year;\n19. Allergy to the ingredients of this investigational drug;\n20. Women who are in pregnancy or nursery;\n21. Participation in clinical study of other traditional Chinese medicine (TCM);\n22. Unsuitability to participate in this study due to other diseases.'}, 'identificationModule': {'nctId': 'NCT03792035', 'briefTitle': 'China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'SP-YFC-03-CTS-AMI'}, 'secondaryIdInfos': [{'id': '2017YFC1700503', 'type': 'OTHER_GRANT', 'domain': 'National Key R&D Program-Research ; Modernization of TCM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year', 'interventionNames': ['Drug: Tongxinluo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Tongxinluo', 'type': 'DRUG', 'description': 'tid, po.', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'tid, po.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangdong Li, MD', 'role': 'CONTACT'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100076', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong-Nan Hu, MD', 'role': 'CONTACT'}], 'facility': 'Beijing Aerospace General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102600', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jixiang Ge, Dean', 'role': 'CONTACT', 'email': 'ge-jx2004@163.com', 'phone': '13716826088'}], 'facility': 'Beijing Renhe Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '053000', 'city': 'Hengshui', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qun Zheng, MD', 'role': 'CONTACT'}], 'facility': 'Harrison International Peace Hospital', 'geoPoint': {'lat': 37.73908, 'lon': 115.68348}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuan-Yu Gao, MD', 'role': 'CONTACT'}], 'facility': 'Henan Provincial Peoples Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '271000', 'city': 'Tai’an', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huan-Yi Zhang, MD', 'role': 'CONTACT'}], 'facility': 'Taian City Central Hospital', 'geoPoint': {'lat': 36.18528, 'lon': 117.12}}, {'zip': '300193', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing-Yuan Mao, MD', 'role': 'CONTACT'}], 'facility': 'First Teaching Hospital of Tianjin University of TCM', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Xiang-Dong Li, MD', 'role': 'CONTACT', 'email': 'fuwai_lxd@163.com', 'phone': '13263138665'}], 'overallOfficials': [{'name': 'Yue-Jin Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant dean', 'investigatorFullName': 'fuwaihospital', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}