Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-11 @ 3:41 AM
Study NCT ID:
NCT00640367
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2008-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-24', 'studyFirstSubmitDate': '2008-03-18', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To asses whether IA thrombolysis vs.IV rt-PA 1.improves the 7 day neurological deficit; 2.is safe on the base of symptomatic intracranial hemorrhages, fatal and non-fatal stroke, death from any cause, neurological deterioration within 7 days', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute ischemic stroke', 'thrombolysis', 'intra-arterial thrombolysis'], 'conditions': ['Stroke', 'Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '23387822', 'type': 'DERIVED', 'citation': 'Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, Boccardi E; SYNTHESIS Expansion Investigators. Endovascular treatment for acute ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):904-13. doi: 10.1056/NEJMoa1213701. Epub 2013 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'SYNTHESIS is a pragmatic multicenter randomized controlled trial (RCT), open-label, with blinded follow-up aiming to determine whether loco-regional intra-arterial (IA) with recombinant tissue-plasminogen activator (rt-PA) and/or mechanical devices, as compared with systemic intravenous (I.V.) infusion of rt-PA within 3 hours of ischemic stroke, increases the proportion of independent survivors at 3 months.', 'detailedDescription': "Eligibility criteria:patients with symptomatic, CT verified, acute ischemic stroke, being able to initiate IV rt-PA within 3 hours and IA thrombolysis within 6 hours of stroke onset, when uncertainty about appropriateness the two approaches exists as established by the treating physician.\n\nEligible patients are randomized to receive either 0.9 mg/kg (max 90 mg) IV rt-PA (control arm) or up to 0.9 mg/Kg IA rt-PA (max 90 mg) over 60 minutes into the thrombus, eventually associated with clot mechanical disaggregation/dislocation or retraction/aspiration. Mechanical thrombolysis is possible also without the use of rt-PA. The procedural choices of the interventional neuroradiologist depend on the type of occlusion, circumstances and experience.\n\nThe study is designed to detect or disprove (alpha=5% and power probability=80%) a 15% absolute difference between the treatment groups in the percentage of patients with a favourable outcome (Modified Rankin Scale Score = 0-1).Enrollment will be completed with 350 randomized patients.\n\nNeurological deficit will be scored with NIH Stroke Scale at day 7 or discharge, or transfer to another hospital, whichever occurs first.Patient's clinical condition will be again evaluated by a telephone call after 90 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sudden focal neurological deficit attributable to a stroke\n* Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset.\n* Age greater than 18 years\n\nExclusion Criteria:\n\n* Disability preceding stroke consistent with a modified Rankin scale score of 2-4\n* Coma at onset\n* Rapidly improving neurological deficit\n* Seizure at onset\n* Clinical presentation suggestive of a subarachnoid hemorrhage\n* Previous history of intracranial hemorrhage\n* Septic embolism\n* Arterial puncture at a non compressible site within the previous 7 days\n* Any traumatic brain injury within the previous 14 days\n* Surgery of the central nervous system in the previous 3 months\n* Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 14 days.\n* Current therapy with intravenous or subcutaneous heparin to rise the clotting time\n* Known hereditary or acquired hemorrhagic diathesis, baseline INR greater than 1.5, aPTT more than 1.5 times normal, or baseline platelet count less than 100,000 per cubic millimeter\n* Baseline blood glucose concentrations below 2.75 mm/L (50 mg/dL).\n* Known contrast sensitivity.\n* Women of childbearing potential (unless pregnancy impossible) or known to be breastfeeding. Uncontrolled hypertension defined by a blood pressure greater or equal 185 mmHg systolic or diastolic greater or equal 110 mm Hg in 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.\n* Prognosis very poor regardless of therapy; likely to be dead within months.\n* Unlikely to be available for follow-up (eg, no fixed home address, visitor from overseas).\n* Any other condition which local investigators feels would pose a significant hazard in terms of risk/benefit to the patient, or if therapies are impracticable.\n\nCOMPUTED TOMOGRAPHIC (CT) SCAN EXCLUSION CRITERIA\n\n* Intracranial tumors except small meningioma\n* Hemorrhage of any degree\n* Acute infarction (since this may be an indicator that the time of onset is uncorrected)'}, 'identificationModule': {'nctId': 'NCT00640367', 'acronym': 'SYNTHESIS EXP', 'briefTitle': 'Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Niguarda Hospital'}, 'officialTitle': 'Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'SYNTHESIS EXPANSION'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IA thrombolysis', 'description': 'IA recombinant tissue plasminogen activator and/or mechanical thrombolysis', 'interventionNames': ['Other: Alteplase IA and/or mechanical thrombolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV rtPA', 'description': 'IV recombinant tissue plasminogen activator', 'interventionNames': ['Drug: Alteplase IV']}], 'interventions': [{'name': 'Alteplase IA and/or mechanical thrombolysis', 'type': 'OTHER', 'description': 'loca intra-arterial recombinant tissue plasminogen activator and/or mechanical thrombolysis', 'armGroupLabels': ['IA thrombolysis']}, {'name': 'Alteplase IV', 'type': 'DRUG', 'description': 'intravenous recombinant tissue plasminogen activator', 'armGroupLabels': ['IV rtPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20162', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': "A.O. Ospedale Ca' Granda", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Alfonso Ciccone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "A.O. Ospedale Niguarda Ca' Granda"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niguarda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}