Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-05 @ 12:18 AM
Study NCT ID:
NCT02921360
Status:
UNKNOWN
Last Update Posted:
2016-10-04
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002545', 'term': 'Brain Ischemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-29', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '3 month'}, {'measure': 'ischemic events', 'timeFrame': '3 month', 'description': 'acute myocardial infarction and ischemic stroke'}, {'measure': 'haemorrhagic events', 'timeFrame': '7 days', 'description': 'intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage'}], 'secondaryOutcomes': [{'measure': 'functional outcome', 'timeFrame': '3 month', 'description': 'defined by modified Rankin scale'}, {'measure': 'artery reocclusion', 'timeFrame': '7 days', 'description': 'verified by CT-angiography'}]}, 'conditionsModule': {'keywords': ['thrombolytic therapy', 'tissue plasminogen activator', 'aspirin'], 'conditions': ['Stroke', 'Brain Ischemia']}, 'referencesModule': {'references': [{'pmid': '23951093', 'type': 'BACKGROUND', 'citation': 'Amaro S, Llull L, Urra X, Obach V, Cervera A, Chamorro A. Risks and benefits of early antithrombotic therapy after thrombolytic treatment in patients with acute stroke. PLoS One. 2013 Aug 8;8(8):e71132. doi: 10.1371/journal.pone.0071132. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether early administration of aspirin in acute ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes due to decreasing the number of early rethromboses.', 'detailedDescription': 'According to the current guidelines (European Stroke Organisation, 2009; American Heart Association-American Stroke Association, 2013) on the systemic thrombolysis in ischemic stroke patients it is recommended (class C) to start antithrombotic therapy (including antiplatelets and anticoagulants) when 24 hours go after alteplase (rtPA, recombinant tissue plasminogen activator) administration. Meanwhile rtPA has wery short lifetime in blood (T1/2 4-6 minutes). Some retrospective studies have found that early administration of antithrombotics (8-16 hours) after systemic thrombolysis can improve functional outcome and does not increase the risk of haemorrhage.\n\nThe investigators suggest a controlled prospective trial to recognise risks and benefits of early administration of aspirin (in 12 hours) after rtPA therapy in patients with acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute ischemic stroke patients treated with rtPA\n* mRS score before current stroke \\<4\n* NIHSS score after rtPA treatment \\<25\n\nExclusion Criteria:\n\n* contraindications for treatment with aspirin\n* contraindications fot iodinated radiocontrast agents administration\n* intracranial haemorrhage after rtPA treatment'}, 'identificationModule': {'nctId': 'NCT02921360', 'briefTitle': 'Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'City Clinical Hospital No. 67, Moscow, Russia'}, 'officialTitle': 'Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'GKB67-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12 hours', 'description': 'Non-contrast CT and CT-angiography are performed in 11 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 12 hours after thrombolysis', 'interventionNames': ['Drug: acetylsalicylic acid']}, {'type': 'NO_INTERVENTION', 'label': '24 hours', 'description': 'Non-contrast CT and CT-angiography are performed in 23 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 24 hours after thrombolysis'}], 'interventions': [{'name': 'acetylsalicylic acid', 'type': 'DRUG', 'otherNames': ['aspirin'], 'armGroupLabels': ['12 hours']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City Clinical Hospital No. 67, Moscow, Russia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}