Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04522102
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2020-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral HaemorrhaGe (ASPIRING)-Pilot Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-22', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'regulatory approvals', 'timeFrame': '6 months', 'description': 'Receipt of regulatory approvals in China，Australia and New Zealand separately, including Ethics, Human Genetics Resources Administration of China (HGRAC).'}], 'secondaryOutcomes': [{'measure': 'trial database', 'timeFrame': '6 months', 'description': 'Trial database structure and data flows that comply with data privacy and information governance regulations in China, Australia and New Zealand.'}, {'measure': 'Site recruitment', 'timeFrame': '12-18 month', 'description': 'Participation of 20 sites in China and 10 sites in Australia and New Zealand'}, {'measure': 'Calculate frequency of clinical data', 'timeFrame': '3 years', 'description': 'Frequency of ICH survivors who are screened, eligible, approached, consented, and randomised by month and site from activation.'}, {'measure': 'Barriers to randomisation of eligible patients.', 'timeFrame': '3 years', 'description': 'Barriers to randomisation of eligible patients.'}, {'measure': 'Frequency of protocol deviations and violations.', 'timeFrame': '3 years', 'description': 'Frequency of protocol deviations and violations.'}, {'measure': 'Adherence to the allocated intervention by investigators and participants', 'timeFrame': '3 years', 'description': 'Adherence to the allocated intervention by investigators and participants'}, {'measure': 'Frequency of withdrawal and loss to follow-up', 'timeFrame': '3 years', 'description': 'Frequency of withdrawal and loss to follow-up'}, {'measure': 'Completeness of follow-up assessments', 'timeFrame': '3 years', 'description': 'Completeness of follow-up assessments'}, {'measure': 'Characteristics of randomised participants compared with eligible patients who were not recruited.', 'timeFrame': '3 years', 'description': 'Characteristics of randomised participants compared with eligible patients who were not recruited.'}, {'measure': 'Frequency of the composite of all serious vascular events', 'timeFrame': '6 months', 'description': 'composite of all serious vascular events (non-fatal stroke, non-fatal myocardial infarction or death from a vascular cause)'}, {'measure': 'Serious adverse event (SAE)', 'timeFrame': 'at least 6 months', 'description': 'any serious adverse event (SAE)'}, {'measure': 'Serious adverse reaction (SAR)', 'timeFrame': 'at least 6 months', 'description': 'serious adverse reaction (SAR)'}, {'measure': 'Suspected Unexpected Serious Adverse Reaction (SUSAR)', 'timeFrame': 'at least 6 months', 'description': 'Suspected Unexpected Serious Adverse Reaction (SUSAR)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'intracerebral hemorrhage', 'antiplatelet therapy', 'aspirin', 'clopidogrel', 'cilostazol'], 'conditions': ['Intracerebral Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '36700520', 'type': 'DERIVED', 'citation': 'Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.'}, {'pmid': '34022170', 'type': 'DERIVED', 'citation': 'Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.'}, {'pmid': '34022160', 'type': 'DERIVED', 'citation': 'Cheng X, Dong Q. Towards individualised secondary prevention after intracerebral haemorrhage. Lancet Neurol. 2021 Jun;20(6):411-413. doi: 10.1016/S1474-4422(21)00130-7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'ASPIRING is an investigator-led, multicentre, prospective, randomised, open-label, blind outcome (PROBE), parallel group, clinical trial. The pilot phase will explore the feasibility of conducting a trial of starting antiplatelet monotherapy versus avoiding antiplatelet therapy for reducing all serious vascular events for adults surviving symptomatic stroke due to spontaneous intracerebral haemorrhage (ICH). The pilot phase will involve \\~120 patients at \\~30 hospitals in China, Australia and New Zealand.', 'detailedDescription': "The participant eligibility criteria specifically identify adults with history of symptomatic spontaneous ICH. Randomisation occurs if a participant and their doctor are uncertain about whether to start or avoid antiplatelet monotherapy at least 24 hours after ICH symptom onset. The intervention is a pragmatic policy of starting antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation). The control group adopts a policy of avoiding antiplatelet therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient age ≥18 years.\n2. Symptomatic stroke due to spontaneous (non-traumatic) ICH.\n3. Patient is at least 24 hours after ICH symptom onset.\n4. Patient and their doctor are both uncertain about whether to start or avoid antiplatelet monotherapy.\n5. Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).\n\nExclusion Criteria:\n\n1. ICH due to head injury, in the opinion of the investigator.\n2. ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator.\n3. Patient is already taking antiplatelet therapy, or full dose anticoagulant therapy, after ICH.\n4. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.\n5. Patient and carer unable to understand spoken or written local language.'}, 'identificationModule': {'nctId': 'NCT04522102', 'briefTitle': 'Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral HaemorrhaGe (ASPIRING)-Pilot Phase', 'organization': {'class': 'OTHER', 'fullName': 'The George Institute for Global Health, China'}, 'officialTitle': 'An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Pilot Study of Antiplatelet Therapy in Patients with a History of Stroke Due to Intracerebral Haemorrhage', 'orgStudyIdInfo': {'id': 'ASPIRING'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Start antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation).", 'interventionNames': ['Drug: Start antiplatelet monotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Comparator', 'description': 'Avoid antiplatelet therapy.'}], 'interventions': [{'name': 'Start antiplatelet monotherapy', 'type': 'DRUG', 'description': "Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100088', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The George Institute for Global Health', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Rustam Al-Shahi Salman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}, {'name': 'Craig S Anderson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Institute'}, {'name': 'Graeme Hankey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Australia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Institute for Global Health, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Edinburgh', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'The University of Western Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}