Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT03491969
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Study of Lipoic Acid on Ischemic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chenhanchuan66@126.com', 'phone': '18459111985', 'title': 'Dr. Hanchuan Chen', 'organization': 'Zhongshan hospital, Fudan University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Alpha-Lipoic Acid(α-LA)', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.\n\nAlpha-Lipoic Acid(α-LA): 200 mg, po, tid', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 138, 'otherNumAffected': 31, 'seriousNumAtRisk': 145, 'deathsNumAffected': 32, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.\n\nPlacebos: 200 mg, po, tid', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 139, 'otherNumAffected': 25, 'seriousNumAtRisk': 144, 'deathsNumAffected': 40, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsened renal function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for Worsened heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Had First Occurrence of the Composite Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpha-Lipoic Acid(α-LA)', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.\n\nAlpha-Lipoic Acid(α-LA): 200 mg, po, tid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.\n\nPlacebos: 200 mg, po, tid'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 24 months', 'description': 'either all-cause death or heart failure (HF) hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alpha-Lipoic Acid(α-LA)', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.\n\nAlpha-Lipoic Acid(α-LA): 200 mg, po, tid'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.\n\nPlacebos: 200 mg, po, tid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alpha-Lipoic Acid(α-LA)', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.\n\nAlpha-Lipoic Acid(α-LA): 200 mg, po, tid'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.\n\nPlacebos: 200 mg, po, tid'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The primary efficacy endpoints were analyzed using the full analysis set (FAS), which followed the Intent-to-Treat (ITT) principle. Inclusion in the FAS required that participants receive the investigational drug for a minimum of 1 month. 300 patients were randomized in a 1:1 ratio to receive either ALA or a matching placebo. In the ALA group, 12 patients were excluded from the primary analysis. In the placebo group, 11 participants were excluded.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-05', 'size': 228509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-24T20:12', 'hasProtocol': True}, {'date': '2025-01-01', 'size': 200856, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-24T20:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2018-04-02', 'resultsFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-24', 'studyFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Had First Occurrence of the Composite Endpoint', 'timeFrame': 'up to 24 months', 'description': 'either all-cause death or heart failure (HF) hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Failure']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy of alpha-lipoic acid(α-LA) on mortality in patients with ischemic heart failure (NYHA Class II - IV and EF =\\< 50%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients ≥ 18 years of age, male or female.\n\n * Patients with a diagnosis of AMI (\\>30 days) according to the global definition. ③Patients with a diagnosis of CHF (NYHA class II-IV) and reduced ejection fraction (EF =\\< 50%) and elevated BNP（NT-proBNP≥600pg/ml or BNP≥150pg/ml; NT-proBNP ≥400 pg/mL or BNP ≥100 pg/mL if patients was hospitalized for heart failure within 12months).\n\n * Patients must be treated with standardized heart failure medications treatment at a stable dose for at least 4 weeks.\n\n * Patients must give written informed consent before any assessment is performed.\n\nExclusion Criteria:\n\n* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.\n\n * allergy to any of the study drugs, drugs of similar chemical classes（Vitamin B） as well as known or suspected contraindications to the study drugs.\n\n * Previous history of intolerance to recommended target doses of α-LA.\n\n * Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).\n\n ⑤ Symptomatic hypotension and/or a SBP \\< 100 mmHg.\n\n ⑥ Severe liver function abnormalities (ALT or AST more than 3 times of the normal upper limit).\n\n ⑦ Estimated GFR \\< 30 mL/min/1.73m2 as measured by the simplified MDRD formula.\n\n ⑧ Serum potassium \\> 5.2 mmol/L.\n\n ⑨ Pregnant women or women preparing for birth.'}, 'identificationModule': {'nctId': 'NCT03491969', 'briefTitle': 'Clinical Study of Lipoic Acid on Ischemic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Clinical Study of Lipoic Acid on Ischemic Heart Failure', 'orgStudyIdInfo': {'id': 'LAoIHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alpha-Lipoic Acid(α-LA)', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.', 'interventionNames': ['Drug: Alpha-Lipoic Acid(α-LA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Alpha-Lipoic Acid(α-LA)', 'type': 'DRUG', 'description': '200 mg, po, tid', 'armGroupLabels': ['Alpha-Lipoic Acid(α-LA)']}, {'name': 'Placebos', 'type': 'DRUG', 'description': '200 mg, po, tid', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Xu Lei', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}