Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT04890366
Status:
UNKNOWN
Last Update Posted:
2022-06-06
First Post:
2021-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-12', 'releaseDate': '2023-10-24'}], 'estimatedResultsFirstSubmitDate': '2023-10-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069462', 'term': 'Dimethyl Fumarate'}], 'ancestors': [{'id': 'D005650', 'term': 'Fumarates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in lesion volume', 'timeFrame': 'baseline to day 7', 'description': 'measured by MRI'}, {'measure': 'changes in hemorrhage volume', 'timeFrame': 'baseline to day 7', 'description': 'measured by MRI'}, {'measure': 'changes in National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'baseline to day 7', 'description': 'The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.'}], 'secondaryOutcomes': [{'measure': 'The Modified Rankin Scale (mRS)', 'timeFrame': 'day1', 'description': 'The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.'}, {'measure': 'The Modified Rankin Scale (mRS)', 'timeFrame': 'day3', 'description': 'The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.'}, {'measure': 'The Modified Rankin Scale (mRS)', 'timeFrame': 'day7', 'description': 'The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.'}, {'measure': 'The Modified Rankin Scale (mRS)', 'timeFrame': 'day14', 'description': 'The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.'}, {'measure': 'The Modified Rankin Scale (mRS)', 'timeFrame': 'day90', 'description': 'The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'day 3', 'description': 'The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'day 7', 'description': 'The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'day 14', 'description': 'The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'day 90', 'description': 'The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dimethyl Fumarate', 'immune modulator', 'Alteplase', 'Acute Ischemic Stroke', 'edema'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in combination with alteplase in patients with Acute Ischemic Stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. more than 18years old\n2. NIHSS scoreā„5\n3. MRI shows anterior circulation infarction\n4. Patients who meet Alteplase thrombolytic therapy within 4.5h\n5. The time from onset to DMF application was less than 24 hours\n\nExclusion Criteria:\n\n1. Hemorrhagic stroke\n2. Patients who have received or plan to receive endovascular therapy\n3. Other diseases of the central nervous system\n4. Pre-existing neurological disability (mRS Score \\>2)\n5. Vertebrobasilar artery obstruction\n6. Difficulty swallowing\n7. Patients who cannot accept MRI examination\n8. Abnormal liver function (transaminase higher than 2 times the normal upper limit)\n9. The lymphocyte count was lower than the lower limit of normal value\n10. Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used\n11. Patients known to have hypersensitivity to dimethyl fumarate or any excipients\n12. Pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT04890366', 'briefTitle': 'Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'haojunwei3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alteplase plus Dimethyl Fumarate', 'interventionNames': ['Drug: Dimethyl Fumarate']}, {'type': 'NO_INTERVENTION', 'label': 'Alteplase'}], 'interventions': [{'name': 'Dimethyl Fumarate', 'type': 'DRUG', 'description': 'Dimethyl fumarate 240mg orally twice daily for 3 consecutive days', 'armGroupLabels': ['Alteplase plus Dimethyl Fumarate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junwei Hao, PhD,MD', 'role': 'CONTACT', 'email': 'haojunwei@vip.163.com'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Junwei Hao, PhD,MD', 'role': 'CONTACT', 'email': 'haojunwei@vip.163.com', 'phone': '010-83199270'}], 'overallOfficials': [{'name': 'Junwei Hao, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-10-24', 'type': 'RELEASE'}, {'date': '2024-04-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xuanwu Hospital, Beijing'}}}}