Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT05395351
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Hospital participation in the Chinese Stroke Centre Alliance (CSCA) was voluntary. To avoid selection bias, all patients were included without sampling when dataset was extracted. The larger sample size and broad geological distribution increased representativeness.\n\nData collected by hospitals were not audited by external chart review. Data reliability depends on training for data abstractors and automated checks to identify erroneous, illogical data entries.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not applicable for this study. All-cause mortality was only collected and reported for group 1 and group 2 for up to 100 days.', 'description': 'This is a non-interventional study using electronic health care records, with data retrieved from the Chinese Stroke Centre Alliance (CSCA). No adverse events were collected on an individual case level. All-cause mortality was only collected and reported for group 1 and group 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 3332, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 88, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 28086, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 211, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment', 'description': 'Group 3: Acute ischemic stroke (AIS) patients aged \\>80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment', 'description': 'Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'OG000'}, {'value': '28086', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '3.2'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '0.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 100 days.', 'description': 'All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase). Endpoint was planned to only include Group 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Hemorrhagic Stroke During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'OG000'}, {'value': '28086', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '7.5'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '3.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 100 days.', 'description': 'Percentage of patients with hemorrhagic stroke during hospitalization.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1404', 'groupId': 'OG000'}, {'value': '10652', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours.', 'description': 'The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2. Only patients with collected NIHSS scores were included in the endpoint.'}, {'type': 'SECONDARY', 'title': 'Modified Rankin Score (mRS) at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2325', 'groupId': 'OG000'}, {'value': '18674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}], 'classes': [{'categories': [{'title': 'mRS score 0', 'measurements': [{'value': '383', 'groupId': 'OG000'}, {'value': '5447', 'groupId': 'OG001'}]}, {'title': 'mRS score 1', 'measurements': [{'value': '612', 'groupId': 'OG000'}, {'value': '6427', 'groupId': 'OG001'}]}, {'title': 'mRS score 2', 'measurements': [{'value': '281', 'groupId': 'OG000'}, {'value': '2131', 'groupId': 'OG001'}]}, {'title': 'mRS score 3', 'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '1393', 'groupId': 'OG001'}]}, {'title': 'mRS score 4', 'measurements': [{'value': '399', 'groupId': 'OG000'}, {'value': '2163', 'groupId': 'OG001'}]}, {'title': 'mRS score 5', 'measurements': [{'value': '346', 'groupId': 'OG000'}, {'value': '902', 'groupId': 'OG001'}]}, {'title': 'mRS score 6', 'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 100 days.', 'description': 'The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Subjects without a discharge mRS score were excluded. Endpoint was planned to only include Group 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Stroke Recurrence During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'OG000'}, {'value': '28086', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}], 'classes': [{'categories': [{'measurements': [{'value': '369', 'groupId': 'OG000'}, {'value': '2039', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 100 days.', 'description': 'Number of patients with stroke recurrence during hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Length of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3318', 'groupId': 'OG000'}, {'value': '27952', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 100 days.', 'description': 'Length of hospitalization.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15865', 'groupId': 'OG000'}, {'value': '97170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.\n\nand Group 3: Acute ischemic stroke (AIS) patients aged \\>80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.\n\nand Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '20.4', 'upperLimit': '21.6'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '29.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.5 hours.', 'description': 'Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission.'}, {'type': 'SECONDARY', 'title': 'Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13639', 'groupId': 'OG000'}, {'value': '84982', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years', 'description': 'Acute ischemic stroke (AIS) patients aged \\>80 years who arrived at the hospital within 3.5 hours of symptom onset and were eligible for recombinant tissue plasminogen activator (rt-PA) treatment.'}, {'id': 'OG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years', 'description': 'Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived at the hospital within 3.5 hours of symptom onset and were eligible for recombinant tissue plasminogen activator (rt-PA) treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '24.6'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '31.8', 'upperLimit': '32.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.5 hours.', 'description': 'Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission and who arrived to the hospital within 3.5 hours of symptom onset and who were eligible for rt-PA treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'FG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'FG002', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment', 'description': 'Group 3: Acute ischemic stroke (AIS) patients aged \\>80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}, {'id': 'FG003', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment', 'description': 'Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3332'}, {'groupId': 'FG001', 'numSubjects': '28086'}, {'groupId': 'FG002', 'numSubjects': '12533'}, {'groupId': 'FG003', 'numSubjects': '69084'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3332'}, {'groupId': 'FG001', 'numSubjects': '28086'}, {'groupId': 'FG002', 'numSubjects': '12533'}, {'groupId': 'FG003', 'numSubjects': '69084'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'In this study the Chinese Stroke Centre Alliance (CSCA) data was used to describe the in-hospital clinical outcomes regarding safety and effectiveness for acute ischemic stroke (AIS) patients who were treated with intravenous recombinant tissue plasminogen activator (IV rt-PA) within 4.5 hours of symptom onset, aged above 80 years, as well as between 18 and 80 years.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'BG000'}, {'value': '28086', 'groupId': 'BG001'}, {'value': '12533', 'groupId': 'BG002'}, {'value': '69084', 'groupId': 'BG003'}, {'value': '113035', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'BG001', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.'}, {'id': 'BG002', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment', 'description': 'Group 3: Acute ischemic stroke (AIS) patients aged \\>80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}, {'id': 'BG003', 'title': 'Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment', 'description': 'Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'BG000'}, {'value': '28086', 'groupId': 'BG001'}, {'value': '12533', 'groupId': 'BG002'}, {'value': '69084', 'groupId': 'BG003'}, {'value': '113035', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '84.4', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '84.9', 'spread': '3.4', 'groupId': 'BG002'}, {'value': '64.2', 'spread': '10.4', 'groupId': 'BG003'}, {'value': '66.8', 'spread': '12.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3332', 'groupId': 'BG000'}, {'value': '28086', 'groupId': 'BG001'}, {'value': '12533', 'groupId': 'BG002'}, {'value': '69084', 'groupId': 'BG003'}, {'value': '113035', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1710', 'groupId': 'BG000'}, {'value': '9188', 'groupId': 'BG001'}, {'value': '6418', 'groupId': 'BG002'}, {'value': '24409', 'groupId': 'BG003'}, {'value': '41725', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1622', 'groupId': 'BG000'}, {'value': '18898', 'groupId': 'BG001'}, {'value': '6115', 'groupId': 'BG002'}, {'value': '44675', 'groupId': 'BG003'}, {'value': '71310', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-22', 'size': 1407393, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-20T04:54', 'hasProtocol': True}, {'date': '2022-01-28', 'size': 1379919, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-13T02:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113035}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2022-05-25', 'resultsFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-13', 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients', 'timeFrame': 'Up to 100 days.', 'description': 'All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Hemorrhagic Stroke During Hospitalization', 'timeFrame': 'Up to 100 days.', 'description': 'Percentage of patients with hemorrhagic stroke during hospitalization.'}, {'measure': 'Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment', 'timeFrame': 'Up to 24 hours.', 'description': 'The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.'}, {'measure': 'Modified Rankin Score (mRS) at Discharge', 'timeFrame': 'Up to 100 days.', 'description': 'The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.'}, {'measure': 'Number of Patients With Stroke Recurrence During Hospitalization', 'timeFrame': 'Up to 100 days.', 'description': 'Number of patients with stroke recurrence during hospitalization.'}, {'measure': 'Length of Hospitalization', 'timeFrame': 'Up to 100 days.', 'description': 'Length of hospitalization.'}, {'measure': 'Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset', 'timeFrame': 'Up to 4.5 hours.', 'description': 'Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset.'}, {'measure': 'Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)', 'timeFrame': 'Up to 4.5 hours.', 'description': 'Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '39477171', 'type': 'DERIVED', 'citation': 'Jiang Y, Wang C, Gu H, Zhou Q, Jiang Y, Li Z, Wang Y. In-hospital outcomes of intravenous recombinant tissue plasminogen activator treatment for acute ischemic stroke in patients aged >80 years: Findings from the Chinese Stroke Center Alliance. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108102. doi: 10.1016/j.jstrokecerebrovasdis.2024.108102. Epub 2024 Oct 28.'}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to find out the in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute ischemic stroke (AIS) patients who were treated with Intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) or did not receive thrombolysis treatment within 4.5 hours of symptom onset, aged ≥18 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient registered in the Chinese Stroke Centre Alliance (CSCA) platform from Aug 2015 to Jul 2019\n* ≥18 years old\n* Diagnosed as Acute Ischemic Stroke (AIS) at admission\n* Arrived or admitted into hospital within 4.5 hours of symptom onset\n* For patients in the iv rt-PA groups only: received IV rt-PA within 4.5 hours of symptom onset\n\nExclusion Criteria:\n\n* Documented Intravenous Thrombolysis (IVT) absolute contraindication\n* Key data missing (age, gender, baseline National Institutes of Health Stroke Scale \\[NIHSS\\], time of symptom onset, IVT treated or not, time of IV alteplase treatment)\n* Received thrombolysis agents other than IV rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)\n* Received endovascular treatment\n* Received IV rt-PA after 4.5 hours of symptom onset'}, 'identificationModule': {'nctId': 'NCT05395351', 'briefTitle': 'Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Characteristics and In-hospital Outcomes of Chinese Elderly (>80 Years) Patients With Acute Ischemic Stroke Receiving Intravenous Recombinant Tissue Plasminogen Activator Treatment Within 4.5 Hours of Symptom Onset', 'orgStudyIdInfo': {'id': '0135-0348'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)', 'description': 'Group 1: Acute ischemic stroke (AIS) patients aged \\>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.', 'interventionNames': ['Drug: rt-PA']}, {'label': 'Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)', 'description': 'Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.', 'interventionNames': ['Drug: rt-PA']}, {'label': 'Acute ischemic stroke (AIS) patients aged >80 years without thrombolysis treatment', 'description': 'Group 3: Acute ischemic stroke (AIS) patients aged \\>80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}, {'label': 'Acute ischemic stroke (AIS) patients aged 18 to 80 years without thrombolysis treatment', 'description': 'Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.'}], 'interventions': [{'name': 'rt-PA', 'type': 'DRUG', 'otherNames': ['Alteplase'], 'description': 'Intravenous recombinant tissue plasminogen activator (IV rt-PA)', 'armGroupLabels': ['Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)', 'Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Boehringer Ingelheim (China) Investment Co., ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}