Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
Study NCT ID:
NCT03997292
Status:
WITHDRAWN
Last Update Posted:
2019-06-25
First Post:
2017-11-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D014568', 'term': 'Urokinase-Type 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study has been terminated due to key change of protocol', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-21', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Economic evaluation', 'timeFrame': 'Day 14', 'description': 'The cost-effectiveness of different thrombolytic drugs'}], 'primaryOutcomes': [{'measure': 'mRS of 90 days after thrombolysis', 'timeFrame': 'Month 3', 'description': 'Proportion of patients with mRS = 0-1 points 90 days after thrombolysis'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Adverse events', 'timeFrame': 'Year 1', 'description': 'Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alteplase; urokinase; intravenous thrombolysis'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China', 'detailedDescription': 'Compare the efficacy and safety of different thrombolytic drugs; Analysis of patients during hospital treatment of adverse events and complications; Analysis of factors that affect the effectiveness of treatment; Evaluate the pharmacological benefits of different thrombolytic drugs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thrombolytic patients with acute ischemic stroke within 3 hours of onset', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) age\\> 18 years old;\n* 2\\) meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke;\n* 3\\) no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1);\n* 4\\) within 3 hours of onset;\n* 5\\) Have measurable neurological deficits;\n* 6\\) Patients or legal guardians can understand and sign informed consent.\n\nExclusion Criteria:\n\n* Absolute exclusion criteria:\n* 1\\) history of head trauma or stroke within the last 3 months;\n* 2\\) suspected subarachnoid hemorrhage;\n* 3\\) history of previous intracranial hemorrhage;\n* 4\\) intracranial tumor, arteriovenous malformation or aneurysm ;\n* 5\\) recent intracranial or intraspinal surgery;\n* 6\\) arterial puncture at an incurable site within the last 7 days;\n* 7\\) elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;\n* 8\\) Internal bleeding;\n* 9\\) acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions;\n* 10\\) heparin treatment within 48 h (APTT is outside the upper limit of normal range);\n* 11\\) oral anticoagulant, INR\\> 1.7 Or PT\\> 15S;\n* 12\\) are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ;\n* 13\\) Blood glucose \\<50 mg / dl (2.7 mmol / L);\n* 14\\) CT suggestive of multiple cerebral infarction (low density range\\> 1/3 of the cerebral hemispheres) ;\n* 15\\) Other conditions considered unsuitable for inclusion in this clinical study;\n* 16\\) 3 months or are participating in other clinical trials;\n* 17\\) combined with severe systemic disease is expected to survive less than three months.\n* Relative exclusion criteria:\n* 1\\) severe stroke (NIHSS\\> 25 points);\n* 2\\) pregnancy;\n* 3\\) neurological deficits after epileptic seizures;\n* 4\\) major surgery or severe trauma within the last 14 days;\n* 5\\) Urethral hemorrhage;\n* 6\\) Myocardial infarction within the last 3 months;'}, 'identificationModule': {'nctId': 'NCT03997292', 'briefTitle': 'Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China', 'orgStudyIdInfo': {'id': 'K201707'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alteplase group', 'description': 'According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion', 'interventionNames': ['Drug: Alteplase']}, {'label': 'Urokinase group', 'description': '1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End', 'interventionNames': ['Drug: Urokinase']}], 'interventions': [{'name': 'Alteplase', 'type': 'DRUG', 'description': 'According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.', 'armGroupLabels': ['Alteplase group']}, {'name': 'Urokinase', 'type': 'DRUG', 'description': '1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.', 'armGroupLabels': ['Urokinase group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'General Hospital of Shenyang Military Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Huisheng Chen, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurology Chief'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurology Chief', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}