Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT06057467
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000925', 'term': 'Anticoagulants'}], 'ancestors': [{'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2351}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early neurological deterioration before discharge', 'timeFrame': 'At discharge, an average of 7 days', 'description': 'NIHSS at discharge increase at least 2 points compared with NIHSS on admission'}], 'secondaryOutcomes': [{'measure': '90-day Composite events', 'timeFrame': '90 days', 'description': 'Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment'}, {'measure': '90-day ischemic stroke', 'timeFrame': '90 days', 'description': 'Ischemic stroke within 90 days after enrollment'}, {'measure': '90-day hemorrhagic stroke', 'timeFrame': '90 days', 'description': 'Hemorrhagic stroke within 90 days after enrollment'}, {'measure': '90-day myocardial infarction', 'timeFrame': '90 days', 'description': 'Myocardial infarction within 90 days after enrollment'}, {'measure': '90-day systemic embolism', 'timeFrame': '90 days', 'description': 'Systemic embolism within 90 days after enrollment'}, {'measure': '90-day major extracranial hemorrhage', 'timeFrame': '90 days', 'description': 'Major extracranial hemorrhage within 90 days after enrollment'}, {'measure': '90-day non-major bleeding', 'timeFrame': '90 days', 'description': 'Non-major bleeding within 90 days after enrollment'}, {'measure': '90-day vascular death', 'timeFrame': '90 days', 'description': 'Vascular death within 90 days after enrollment'}, {'measure': '90-day all-cause death', 'timeFrame': '90 days', 'description': 'All-cause death within 90 days after enrollment'}, {'measure': 'Discharge mRS', 'timeFrame': 'At discharge, an average of 7 days', 'description': 'Modified Rankin scale at discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in acute ischemic stroke (AIS) patients with non-valvular atrial fibrillation (NVAF). Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is early neurological deterioration (END) before discharge.', 'detailedDescription': 'Anticoagulation therapy is effective to prevent ischemic stroke in patients with NVAF who have a history of stroke. Recent clinical trials have demonstrated that early initiation of anticoagulation therapy after AIS is safe, while no remarkable benefits have been observed. The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in AIS patients with non-NVAF. Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is END before discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Acute ischemic stroke with onset \\< 48 hours\n* Have a history or newly diagnosed as NVAF\n* NIHSS on admission \\<= 8\n\nExclusion Criteria:\n\n* Chronic renal dysfunction (GFR \\< 30ml/min) or severe hepatic injury\n* Have a history or newly diagnosed as valvular heart disease\n* Mural thrombus in heart\n* Contraindications of anticoagulation therapy within 12 days after AIS, e.g. severe intracranial hemorrhage\n* Received reperfusion therapy, e.g. intravenous thrombolysis and endovascular treatment\n* Concomitant stenosis (\\>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory\n* Life expectancy less than 1 year\n* Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding\n* Pregnant or lactating women\n* Individuals identified by researchers as unsuitable for participation in the study due to other reasons.'}, 'identificationModule': {'nctId': 'NCT06057467', 'acronym': 'ASAP', 'briefTitle': 'Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'ASAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early initiation of anticoagulation', 'description': 'For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 0-3 days of onset.\n\nFor patients with NIHSS 4-8, anticoagulation therapy will be initiated within 4-6 days of onset.', 'interventionNames': ['Drug: Anticoagulation Agents']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late initiation of anticoagulation', 'description': 'For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 4-12 days of onset.\n\nFor patients with NIHSS 4-8, anticoagulation therapy will be initiated within 7-12 days of onset.', 'interventionNames': ['Drug: Anticoagulation Agents']}], 'interventions': [{'name': 'Anticoagulation Agents', 'type': 'DRUG', 'description': 'Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban.', 'armGroupLabels': ['Early initiation of anticoagulation', 'Late initiation of anticoagulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Lou, PhD', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '8657187784811'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jiaxing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoling Zhang', 'role': 'CONTACT'}], 'facility': 'Jiaxing Second Hospital', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}], 'centralContacts': [{'name': 'Min Lou, PhD', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '+8613958007213'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}