Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT03772457
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2017-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}], '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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2017-10-10', 'studyFirstSubmitQcDate': '2018-12-09', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment', 'timeFrame': '14 days after enrolling'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Stroke', 'Intracranial Hemorrhages', 'Anticoagulant', 'Matrix Metalloproteinases']}, 'descriptionModule': {'briefSummary': 'This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed ischemic stroke/TIA patients with NVAF who sign the informed consent and receiveRivaroxaban treatment in the in-patient ward.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, ageā„18;\n2. Were newly diagnosed asischemic stroke/TIA concomitant NVAF;\n3. Prescribedand accept Rivaroxaban;\n4. Sign thewritten informed consent.\n\nExclusion Criteria:\n\n1. Renal impairment (CrCl\\<15 ml/min) or severe hepatic impairment.\n2. Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition).\n3. Stroke or TIA caused by large artery atherosclerosis\n4. Planned major surgery or invasive intervention\n5. Active internal bleeding\n6. Malignancy or other serious medical conditions with a life expectancy \\<6 months\n7. Allergery to Rivaroxaban\n8. Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT03772457', 'briefTitle': 'Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban', 'orgStudyIdInfo': {'id': 'InV HT RAF 1010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'new oral anticoagulant molecules which is the selective factor Xa inhibitor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'MIN LOU, Ph.D.', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '8657187784811'}, {'name': 'MIN LOU, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Lou, PhD', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '13958007213'}], 'overallOfficials': [{'name': 'Min Lou, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Taizhou Hospital', 'class': 'OTHER'}, {'name': "Zhuji People's hospital", 'class': 'UNKNOWN'}, {'name': "Shaoxing People's Hospital", 'class': 'OTHER'}, {'name': 'Jinhua Central Hospital', 'class': 'OTHER'}, {'name': "HaiyanPeople's hospital", 'class': 'UNKNOWN'}, {'name': 'Wenzhou Central Hospital', 'class': 'OTHER'}, {'name': 'The Central Hospital of Lishui City', 'class': 'OTHER'}, {'name': "Dongyang People's Hospital", 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}