Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02164357
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2014-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death within 90 days after onset', 'timeFrame': '90 days'}, {'measure': 'Symptomatic intracranial haemorrhage', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Stroke recovery rate after discharge', 'timeFrame': 'From onset to discharge', 'description': 'Recovery defined as a 10-fold decrease in NIHSS or NIHSS (7 days after onset or at discharge)'}, {'measure': 'Functional recovery', 'timeFrame': '4.5 hours after onset', 'description': 'Modified Rankin Score (RMS) value'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ischaemic Stroke', 'Main artery occlusion', 'Endovascular treatment', 'Intravenous Thrombolytic Therapy'], 'conditions': ['Acute Ischaemic Stroke']}, 'referencesModule': {'references': [{'pmid': '27821473', 'type': 'DERIVED', 'citation': 'Alonso de Lecinana M, Martinez-Sanchez P, Garcia-Pastor A, Kawiorski MM, Calleja P, Sanz-Cuesta BE, Diaz-Otero F, Frutos R, Sierra-Hidalgo F, Ruiz-Ares G, Fandino E, Diez-Tejedor E, Gil-Nunez A, Fuentes B. Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis: a prospective observational study. J Neurointerv Surg. 2017 Nov;9(11):1041-1046. doi: 10.1136/neurintsurg-2016-012727. Epub 2016 Nov 7.'}, {'pmid': '26838587', 'type': 'DERIVED', 'citation': 'Kawiorski MM, Martinez-Sanchez P, Garcia-Pastor A, Calleja P, Fuentes B, Sanz-Cuesta BE, Lourido D, Marin B, Diaz-Otero F, Vicente A, Sierra-Hidalgo F, Ruiz-Ares G, Diez-Tejedor E, Fandino E, Alonso de Lecinana M. Alberta Stroke Program Early CT Score applied to CT angiography source images is a strong predictor of futile recanalization in acute ischemic stroke. Neuroradiology. 2016 May;58(5):487-93. doi: 10.1007/s00234-016-1652-7. Epub 2016 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients younger than 80 with acute ischemic stroke produced by a main artery oclussion with a NIHSS \\> 6 (National Institute of Health Stroke Scale) receiving IVT or EVT within 4.5 hours after onset.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 80 or less years old patients with acute stroke produced by a main artery occlusion\n* NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment)\n* Patients receiving EVT or IVT within 4.5 hours after onset\n\nExclusion Criteria:\n\n* EVT or IVT contraindication\n* Previous neurological impairment, severe concomitant disease or poor prognosis.\n* Pregnancy or breastfeeding\n* Known hypersensitivity to any study drugs\n* Severe organic disease for which there is not risk compensation.'}, 'identificationModule': {'nctId': 'NCT02164357', 'acronym': 'FUN-TPA', 'briefTitle': 'Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset: A Prospective Cohorts Study', 'orgStudyIdInfo': {'id': 'FUN-TPA-2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EVT', 'description': 'Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated', 'interventionNames': ['Procedure: EVT (endovascular treatment )']}, {'label': 'IVT + EVT', 'description': 'Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset', 'interventionNames': ['Procedure: EVT (endovascular treatment )', 'Procedure: IVT (intravenous thrombolytic therapy)']}, {'label': 'IVT (intravenous thrombolytic therapy)', 'description': 'Patients that will received IVT only within 4.5 hours after onset', 'interventionNames': ['Procedure: IVT (intravenous thrombolytic therapy)']}], 'interventions': [{'name': 'EVT (endovascular treatment )', 'type': 'PROCEDURE', 'armGroupLabels': ['EVT', 'IVT + EVT']}, {'name': 'IVT (intravenous thrombolytic therapy)', 'type': 'PROCEDURE', 'armGroupLabels': ['IVT (intravenous thrombolytic therapy)', 'IVT + EVT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Doce de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}