Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 1:14 AM
Study NCT ID:
NCT04309357
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2020-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombolysis Outcome in Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemic stroke outcome', 'timeFrame': '3 months', 'description': 'evaluation of alteplase effect in morbidity of patient by using barthel index'}], 'secondaryOutcomes': [{'measure': 'ischemic stroke mortality', 'timeFrame': '3 months', 'description': 'mortality of patients who received alteplase'}, {'measure': 'frequency of adverse event', 'timeFrame': '3 months', 'description': 'number of any adverse event of alteplase during study'}, {'measure': 'frequency of fatal adverse event', 'timeFrame': '3 months', 'description': 'number of fatal adverse event of alteplase during study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute', 'Thrombolytic Therapy', 'Alteplase', 'Mortality']}, 'descriptionModule': {'briefSummary': 'Consecutive patients with diagnosis of acute ischemic stroke and candidate of thrombolytic therapy during Jan 2017-Mar 2019 in BuAli Sina Hospital ,Sari, Iran, enrolled to this cohort study.\n\nThe demographic data, stroke characteristis, lab data and ... recorded. Then patients evaluate every 3 month until 12 month for fallow up.', 'detailedDescription': 'The variables of the study, including demographic characteristics, risk factors, complete drug history, nosocomial infection and other in-hospital events, hemorrhagic complications, duration of hospitalization,door to needle time, symptom to needle time, clinical and imaging characteristics of resent stroke, laboratory data including fasting blood glucose, lipid profile (total cholesterol, triglyceride, LDL, HDL), hematology markers (CBC diff, HGB, platelet), coagulation markers (PT, PTT, INR), liver function test (ALT, AST, ALP, Bill) and renal function test (BUN, Cr, Cr cl) were collected. All patients underwent a brain computed tomography scan early on the admission and after 24 hours. Cardiological evaluation including Electrocardiogram and echocardiography performed for all patients. Carotid and vertebrobasillar assessed by Doppler ultrasound or magnetic resonance angiography (MRA).\n\nStroke severity estimated by using modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale(NIHSS) scores on the first day of admission and at discharge by a neurology resident. Then patient evaluate every 3 months until 12 m for fallow up and in each visit vital sign, patient clinical status, any event, Barthel index was recorded.\n\nSafety endpoints of this study were any adverse events clinically relevant to alteplase, specially hemorrhagic complications.\n\nAll patients who met all inclusion and exclusion criteria treated with 0.9 mg/kg recombinant tissue plasminogen activator (Actilyse, Boehringer Industry, Germany) up to maximum of 90 mg, 10% of which was injected as a blous dose and remainder infused over an hour.\n\nPrimary outcome of this study was alteplase effect in reduce morbidity rate defined by NIHSS and mRS score reduction and rate of functional independence at 3,6 and 12 months Barthel index in fallow up. Minimal clinically important difference defined as reduce NIHSS score at least 25% or MRS score 2 point at discharge day in comparison to admission day. In fallow up evaluations Barthel index 85-100 was considered favorable outcome. Binary outcomes included independence compared with disability or death.\n\nSecondary outcome was rtPA therapy safety that assessed by fatal intra cranial hemorrhage. Also, mortality rate, intracranial hemorrhage rate, any hemorrhagic event rate and any adverse event rate assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patient with diagnosis of acute ischemic stroke that met all criteria of thrombolytic therapy, that reffered to Bu Ali Sina hospital during jan 2017-mar 2019, enrolled to this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. writen inform consent\n2. diagnosis of acute ischemic stroke by neurologist\n3. met all criteria of thrombolytic therapy\n4. resived full dose of alteplase\n\nExclusion Criteria:\n\n1. any contraindication of thrombolytic therapy\n2. resived lower than 0.9 mg/kg alteplase'}, 'identificationModule': {'nctId': 'NCT04309357', 'acronym': 'TOSSI', 'briefTitle': 'Thrombolysis Outcome in Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Mazandaran University of Medical Sciences'}, 'officialTitle': 'Evaluation of Thrombolytic Therapy in Acute Ischemic Stroke Outcome: A Cohort Study From North of Iran', 'orgStudyIdInfo': {'id': '2464'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['recombinant tissue plasminogen activator'], 'description': 'Alteplase in dose 0.9 mg/kg in acute ischemic patient with indications of thrombolytic therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sari', 'country': 'Iran', 'facility': 'Bu Ali Sina hospital , Mazandarn University of Medical Science', 'geoPoint': {'lat': 36.56332, 'lon': 53.06009}}], 'overallOfficials': [{'name': 'Sharifi-Razavi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mazandaran University of Medical Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mazandaran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in neurology', 'investigatorFullName': 'Athena Sharifi Razavi', 'investigatorAffiliation': 'Mazandaran University of Medical Sciences'}}}}