Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-06 @ 9:55 PM
Study NCT ID:
NCT04041167
Status:
UNKNOWN
Last Update Posted:
2019-08-02
First Post:
2019-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes (IMPORTANT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with functional independence', 'timeFrame': '3 months', 'description': 'The modified Rankin Scale (mRS) consists of 7 levels, ranging from perfect health without symptoms (mRS score 0) to death (mRS score 6). We defined functional independence as mRS scores of 0-2 at 3 months after stroke.'}], 'secondaryOutcomes': [{'measure': 'Rate of mortality', 'timeFrame': '3 months', 'description': 'All cause of death within 3 months'}, {'measure': 'Number of participants with BBB breakdown', 'timeFrame': '1 week', 'description': 'Hemorrhagic transformation within 1 week, Brain edema at 1 week after stroke'}, {'measure': 'Number of participants with early neurological deterioration', 'timeFrame': '2 weeks', 'description': 'early neurological deterioration is defined as an increase of ≥1 point in motor power or an increase of ≥2 points in the total NIHSS score within 2 weeks'}, {'measure': 'Number of participants with major bleeding', 'timeFrame': '3 months', 'description': 'Intracranial and extracranial bleeding within 3 months'}, {'measure': 'Number of participants with recurrence', 'timeFrame': '3 months', 'description': 'Recurrent stroke within 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reperfusion', 'Lipoic acid', 'Stroke'], 'conditions': ['Stroke, Ischemic']}, 'referencesModule': {'references': [{'pmid': '27677185', 'type': 'BACKGROUND', 'citation': 'Choi KH, Park MS, Kim JT, Kim HS, Kim JH, Nam TS, Choi SM, Lee SH, Kim BC, Kim MK, Cho KH. Lipoic Acid Use and Functional Outcomes after Thrombolysis in Patients with Acute Ischemic Stroke and Diabetes. PLoS One. 2016 Sep 27;11(9):e0163484. doi: 10.1371/journal.pone.0163484. eCollection 2016.'}, {'pmid': '25761600', 'type': 'BACKGROUND', 'citation': 'Choi KH, Park MS, Kim HS, Kim KT, Kim HS, Kim JT, Kim BC, Kim MK, Park JT, Cho KH. Alpha-lipoic acid treatment is neurorestorative and promotes functional recovery after stroke in rats. Mol Brain. 2015 Feb 11;8:9. doi: 10.1186/s13041-015-0101-6.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effectiveness and safety of alpha-lipoic acid in patients with diabetes and ischemic stroke treated with reperfusion therapy.', 'detailedDescription': 'Despite significant advances in the prevention and treatment of stroke, it is still one of the leading causes of death and debilitating disease. Unfortunately, several neuroprotective strategies have failed in clinical trials. At present, it is reported that there are no pharmacological agents with putative neuroprotective actions that have demonstrated efficacy in improving outcomes after acute ischemic stroke (AIS) in humans. Previous stroke studies have confirmed that oxidative stress plays a vital role in stroke and in reperfusion following stroke. Therefore, the use of antioxidants could be a promising strategy for treating ischemia-reperfusion injury. Alpha-lipoic acid (aLA) is a potent antioxidant commonly used for the treatment of diabetic polyneuropathy (DPNP). The investigators previously demonstrated the neuroprotective and neurorestorative effects of aLA, mediated at least partially via insulin receptor activation, after cerebral ischemia in rats. Moreover, previous observational study of the investigators showed that patients with diabetes treated with aLA have better functional outcomes following AIS after reperfusion therapy than patients not using aLA.\n\nTherefore, the investigators investigate whether patients with diabetes treated with aLA have better functional outcomes after AIS and reperfusion therapy than patients not treated with aLA in this prospective randomized trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute ischemic stroke within 6 hours of symptom onset\n* Patients with diabetes\n* Patients who underwent reperfusion therapy (Intravenous t-PA or endovascular thrombectomy)\n\nExclusion Criteria:\n\n* Pre-existing disability (Modified Rankin Scale \\>= 1)\n* Patients with severe renal disease (GFR \\<30 ml / min)\n* Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure'}, 'identificationModule': {'nctId': 'NCT04041167', 'briefTitle': 'Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes (IMPORTANT)', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes', 'orgStudyIdInfo': {'id': 'IMPORTANT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alpha lipoic acid', 'description': 'All patients will be assigned intravenous alpha lipoic acid 600mg within 24 hours of symptom onset. Patients will receive intravenous alpha lipoic acid 600mg/day for one week, followed by an oral pill of alpha lipoic acid 600mg/day for three months.', 'interventionNames': ['Drug: alpha lipoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'All patients will receive intravenous normal saline within 24 hours of symptom onset.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'alpha lipoic acid', 'type': 'DRUG', 'otherNames': ['thioctacid'], 'description': 'alpha lipoic acid treatment', 'armGroupLabels': ['Alpha lipoic acid']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'No alpha lipoic acid treatment', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kangho Choi, MD, PhD', 'role': 'CONTACT', 'email': 'ckhchoikang@hanmail.net', 'phone': '82-62-220-6137'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'centralContacts': [{'name': 'Kangho Choi, MD, PhD', 'role': 'CONTACT', 'email': 'ckhchoikang@hanmail.net', 'phone': '82-62-220-6137'}], 'overallOfficials': [{'name': 'Kangho Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'We will share the data for one year after the end of the study.', 'ipdSharing': 'YES', 'description': 'IPD will be shared with other researchers.', 'accessCriteria': 'If a proposal for a joint research or a sub-study is proposed, the approval will be decided through a meeting of the committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chosun University Hospital', 'class': 'OTHER'}, {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, {'name': 'Wonkwang University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Kangho Choi', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}