Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-26 @ 11:52 AM
Study NCT ID:
NCT04624295
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2020-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 294}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with modified Rankin scale (mRS) ≤2', 'timeFrame': '90 days', 'description': 'The proportion of patients with modified Rankin scale (mRS) ≤2 at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)\\].'}], 'secondaryOutcomes': [{'measure': 'Hemorrhage enlargement after intravenous thrombolysis', 'timeFrame': '7 days', 'description': 'Hemorrhage enlargement after intravenous thrombolysis at 7 days'}, {'measure': 'Hemorrhage reduction after intravenous thrombolysis', 'timeFrame': '7 days', 'description': 'Hemorrhage reduction after intravenous thrombolysis at 7 days'}, {'measure': 'the progress of National Institute of Health Stroke Scale (NIHSS) scores', 'timeFrame': '7 days', 'description': 'the progress of National Institute of Health Stroke Scale (NIHSS) scores at 7 days, on which scores range from 0 (no neurologic deficit) to 42 (severe)\\]'}, {'measure': 'the distribution of modified Rankin scale (mRS)', 'timeFrame': '90 days', 'description': 'the distribution of modified Rankin scale (mRS) at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)\\]'}, {'measure': 'Recurrence rate of acute ischemic stroke', 'timeFrame': '90 days', 'description': 'Recurrence rate of acute ischemic stroke at 90 days'}, {'measure': 'Recurrence rate of cerebrovascular disease', 'timeFrame': '90 days', 'description': 'Recurrence rate of cerebrovascular disease at 90 days'}, {'measure': 'Recurrence rate of acute ischemic stroke', 'timeFrame': '1 year', 'description': 'Recurrence rate of acute ischemic stroke at 1 years'}, {'measure': 'Recurrence rate of cerebrovascular disease', 'timeFrame': '1 year', 'description': 'Recurrence rate of cerebrovascular disease at 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'intravenous thrombolysis', 'Hemorrhagic Infarction', 'antiplatelet therapy'], 'conditions': ['Antiplatelet Therapy', 'Hemorrhagic Infarction']}, 'descriptionModule': {'briefSummary': 'Previous study showed that the proportions of hemorrhagic Infarction after intravenous thrombolysis were 24.2% and 32.5% in the control group and the alteplase group, and most of them were asymptomatic. Hemorrhagic Infarction was a part of the natural progression after acute ischemic stroke. Previous study have shown no significant relationship between hemorrhagic Infarction and poor outcome in acute ischemic stroke (AIS) patients. In this study, a randomized controlled trial will be conducted to explore the efficacy and safety of early antiplatelet therapy after hemorrhagic infarction in acute ischemic stroke treated with intravenous thrombolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute ischemic patients receiving intravenous thrombolysis within 24 hours upon stroke onset\n2. Be confirmed as Hemorrhagic Infarction at 24 to 36 hours after intravenous thrombolysis by computerized tomography\n3. The patient or family member signed an informed consent\n\nExclusion Criteria:\n\n1. Early use of anticoagulant drugs within 1 week after intravenous thrombolysis;\n2. Tirofiban was used after receiving endovascular treatment;\n3. Intraoperative stent placement after receiving endovascular treatment;\n4. Subarachnoid hemorrhage or ventricular hemorrhage;\n5. There are contraindications for aspirin use;'}, 'identificationModule': {'nctId': 'NCT04624295', 'briefTitle': 'Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HITs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early Antiplatelet Therapy', 'interventionNames': ['Drug: Early aspirin Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Early Antiplatelet Therapy', 'interventionNames': ['Drug: Non-Early aspirin Therapy']}], 'interventions': [{'name': 'Early aspirin Therapy', 'type': 'DRUG', 'description': 'Early Antiplatelet Therapy is administered within 24 to 48 hours after stroke onset and the dose is determined by the clinician. Aspirin was chosen for antiplatelet therapy.', 'armGroupLabels': ['Early Antiplatelet Therapy']}, {'name': 'Non-Early aspirin Therapy', 'type': 'DRUG', 'description': 'Antiplatelet therapy will be delayed to beyond 48 hours after stroke onset and may not be initiated until hemorrhagic Infarction has been confirmed absorbed.', 'armGroupLabels': ['Non-Early Antiplatelet Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Lou', 'role': 'CONTACT'}], 'facility': 'the second affiliated hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Lou, PhD', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '+8657187784810'}], 'overallOfficials': [{'name': 'Min Lou, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': "Shaoxing People's Hospital", 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Jiaxing University', 'class': 'OTHER'}, {'name': 'Huzhou Central Hospital', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Jiaxing University', 'class': 'OTHER'}, {'name': 'Jinhua Central Hospital', 'class': 'OTHER'}, {'name': 'Taizhou Hospital', 'class': 'OTHER'}, {'name': 'Ningbo Medical Center Lihuili Hospital', 'class': 'OTHER_GOV'}, {'name': 'Ningbo No.2 Hospital', 'class': 'OTHER'}, {'name': "Lishui Country People's Hospital", 'class': 'OTHER'}, {'name': 'Wenzhou Central Hospital', 'class': 'OTHER'}, {'name': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}