Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:17 AM
Study NCT ID:
NCT04290494
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2020-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Temporal Trends of Thrombolysis Treatment in Chinese Acute Ischemic Stroke (AIS) Patients From 2007-2017: Analysis of China National Stroke Registry (CNSR) I, II, and III; CTP-Draft Review Performed;
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.\n\nInvestigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.\n\nBI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not collected for this study.', 'description': 'As this was a non-interventional study with secondary use of existing data from China National Stroke Registry (CNSR) I, II, and III database, safety data were not collected and adverse events reporting on an individual case level is not applicable. The "0" in the Number Affected and Number At Risk in the All-Cause Mortality, Serious Adverse Event, and Other (non-serious) Adverse Events sections stands for mortality, serious and other (non-serious) adverse events were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among 2 Hours Intravenous Thrombolytics (IVT) Eligible Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '866', 'groupId': 'OG000'}, {'value': '2214', 'groupId': 'OG001'}, {'value': '1679', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.66', 'groupId': 'OG000', 'lowerLimit': '9.53', 'upperLimit': '13.80'}, {'value': '10.66', 'groupId': 'OG001', 'lowerLimit': '9.37', 'upperLimit': '11.94'}, {'value': '28.77', 'groupId': 'OG002', 'lowerLimit': '26.60', 'upperLimit': '30.93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 3 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 2 hours since symptom onset was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 2 hours since symptom onset were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among 3.5 Hours Intravenous Thrombolytics (IVT) Eligible Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1271', 'groupId': 'OG000'}, {'value': '3684', 'groupId': 'OG001'}, {'value': '2787', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.53', 'groupId': 'OG000', 'lowerLimit': '11.65', 'upperLimit': '15.41'}, {'value': '7.11', 'groupId': 'OG001', 'lowerLimit': '6.28', 'upperLimit': '7.94'}, {'value': '33.44', 'groupId': 'OG002', 'lowerLimit': '31.69', 'upperLimit': '35.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 4.5 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 3.5 hours since symptom onset was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 3.5 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Arrived at Hospital Within 2 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among All Eligible Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10968', 'groupId': 'OG000'}, {'value': '17823', 'groupId': 'OG001'}, {'value': '13397', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '1.10'}, {'value': '1.32', 'groupId': 'OG001', 'lowerLimit': '1.16', 'upperLimit': '1.49'}, {'value': '3.61', 'groupId': 'OG002', 'lowerLimit': '3.29', 'upperLimit': '3.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'Percentage of patients who arrived at hospital within 2 hours of symptom onset and who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 3 hours of symptom onset among all eligible patients was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Arrived at Hospital Within 3.5 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among All Eligible Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10968', 'groupId': 'OG000'}, {'value': '17823', 'groupId': 'OG001'}, {'value': '13397', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '1.80'}, {'value': '1.47', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '1.65'}, {'value': '6.96', 'groupId': 'OG002', 'lowerLimit': '6.53', 'upperLimit': '7.39'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'Percentage of patients who arrived at hospital within 3.5 hours of symptom onset and who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 4.5 hours of symptom onset among all eligible patients was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017.'}, {'type': 'SECONDARY', 'title': 'The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 3 Hours IV-rtPA Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '120.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '74.0', 'upperLimit': '113.0'}, {'value': '58.0', 'groupId': 'OG002', 'lowerLimit': '38.0', 'upperLimit': '77.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 170 minutes.', 'description': 'The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) ≤ 60 Minutes Among 3 Hours IV-rtPA Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.71', 'groupId': 'OG000', 'lowerLimit': '19.89', 'upperLimit': '37.54'}, {'value': '12.29', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '16.48'}, {'value': '59.21', 'groupId': 'OG002', 'lowerLimit': '54.83', 'upperLimit': '63.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients with door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) ≤ 60 minutes among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '32.0', 'upperLimit': '90.0'}, {'value': '59.0', 'groupId': 'OG001', 'lowerLimit': '43.0', 'upperLimit': '75.0'}, {'value': '69.0', 'groupId': 'OG002', 'lowerLimit': '50.0', 'upperLimit': '93.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From symptom onset until arrival at the hospital, up to 120 minutes.', 'description': 'Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '150.0', 'groupId': 'OG000', 'lowerLimit': '138.0', 'upperLimit': '170.0'}, {'value': '156.0', 'groupId': 'OG001', 'lowerLimit': '141.0', 'upperLimit': '165.0'}, {'value': '134.0', 'groupId': 'OG002', 'lowerLimit': '108.0', 'upperLimit': '155.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes.', 'description': 'Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 4.5 Hours IV-rtPA Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '932', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '130.0'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': '112.0'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '38.0', 'upperLimit': '84.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 minutes.', 'description': 'The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) ≤ 60 Minutes Among 4.5 Hours IV-rtPA Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '932', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.74', 'groupId': 'OG000', 'lowerLimit': '20.13', 'upperLimit': '33.36'}, {'value': '13.36', 'groupId': 'OG001', 'lowerLimit': '9.24', 'upperLimit': '17.48'}, {'value': '53.43', 'groupId': 'OG002', 'lowerLimit': '50.23', 'upperLimit': '56.64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients with door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) ≤ 60 minutes among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '932', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '110.0'}, {'value': '59.0', 'groupId': 'OG001', 'lowerLimit': '45.0', 'upperLimit': '84.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '60.0', 'upperLimit': '140.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From symptom onset until arrival at the hospital, up to 210 minutes.', 'description': 'Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '983', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'OG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'OG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '175.0', 'groupId': 'OG000', 'lowerLimit': '150.0', 'upperLimit': '200.0'}, {'value': '159.0', 'groupId': 'OG001', 'lowerLimit': '144.0', 'upperLimit': '169.0'}, {'value': '170.0', 'groupId': 'OG002', 'lowerLimit': '132.0', 'upperLimit': '210.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes.', 'description': 'Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017. Only those patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'FG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'FG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10968'}, {'groupId': 'FG001', 'numSubjects': '17823'}, {'groupId': 'FG002', 'numSubjects': '13397'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10968'}, {'groupId': 'FG001', 'numSubjects': '17823'}, {'groupId': 'FG002', 'numSubjects': '13397'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This non-interventional study was based on Chinese acute ischemic stroke patients who had treatment from 2007 to 2017 from the existing data of the China National Stroke Registry (CNSR) I, II, and III to investigate the temporal trends of thrombolysis treatment in Chinese acute ischemic stroke patients.', 'preAssignmentDetails': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I, II, and III with treatment from 2007 to 2017 were included.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10968', 'groupId': 'BG000'}, {'value': '17823', 'groupId': 'BG001'}, {'value': '13397', 'groupId': 'BG002'}, {'value': '42188', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'China National Stroke Registry (CNSR) I (2007 to 2008)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) I (data in this existing database were collected during 2007-2008) were included in this group.'}, {'id': 'BG001', 'title': 'China National Stroke Registry (CNSR) II (2012 to 2013)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) II (data in this existing database were collected during 2012-2013) were included in this group.'}, {'id': 'BG002', 'title': 'China National Stroke Registry (CNSR) III (2015 to 2017)', 'description': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) III (data in this existing database were collected during 2015-2017) were included in this group.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10968', 'groupId': 'BG000'}, {'value': '17823', 'groupId': 'BG001'}, {'value': '13397', 'groupId': 'BG002'}, {'value': '42188', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '63.5', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '62.5', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10968', 'groupId': 'BG000'}, {'value': '17823', 'groupId': 'BG001'}, {'value': '13397', 'groupId': 'BG002'}, {'value': '42188', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4053', 'groupId': 'BG000'}, {'value': '6350', 'groupId': 'BG001'}, {'value': '4114', 'groupId': 'BG002'}, {'value': '14517', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6915', 'groupId': 'BG000'}, {'value': '11473', 'groupId': 'BG001'}, {'value': '9283', 'groupId': 'BG002'}, {'value': '27671', 'groupId': 'BG003'}]}]}], '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'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All eligible patients who met all inclusion and none of the exclusion criteria from the existing data of China National Stroke Registry (CNSR) phase I to phase III with treatment from 2007 to 2017.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-17', 'size': 375555, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-03T11:11', 'hasProtocol': True}, {'date': '2020-11-03', 'size': 515917, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-03T11:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42188}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2020-02-27', 'resultsFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-04', 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among 2 Hours Intravenous Thrombolytics (IVT) Eligible Patients', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 3 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 2 hours since symptom onset was reported.'}, {'measure': 'Percentage of Patients Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among 3.5 Hours Intravenous Thrombolytics (IVT) Eligible Patients', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 4.5 hours of symptom onset among patients eligible for intravenous thrombolytics (IVT) who arrived at the hospital within 3.5 hours since symptom onset was reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Who Arrived at Hospital Within 2 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 3 Hours of Symptom Onset Among All Eligible Patients', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'Percentage of patients who arrived at hospital within 2 hours of symptom onset and who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 3 hours of symptom onset among all eligible patients was reported.'}, {'measure': 'Percentage of Patients Who Arrived at Hospital Within 3.5 Hours of Symptom Onset and Who Received Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Within 4.5 Hours of Symptom Onset Among All Eligible Patients', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'Percentage of patients who arrived at hospital within 3.5 hours of symptom onset and who received Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment within 4.5 hours of symptom onset among all eligible patients was reported.'}, {'measure': 'The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 3 Hours IV-rtPA Treated Patients', 'timeFrame': 'From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 170 minutes.', 'description': 'The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.'}, {'measure': 'Percentage of Patients With Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) ≤ 60 Minutes Among 3 Hours IV-rtPA Treated Patients', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients with door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) ≤ 60 minutes among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.'}, {'measure': 'Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients', 'timeFrame': 'From symptom onset until arrival at the hospital, up to 120 minutes.', 'description': 'Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.'}, {'measure': 'Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients', 'timeFrame': 'From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes.', 'description': 'Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 3 hours since symptom onset was reported.'}, {'measure': 'The Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) Among 4.5 Hours IV-rtPA Treated Patients', 'timeFrame': 'From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 minutes.', 'description': 'The door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.'}, {'measure': 'Percentage of Patients With Door to Needle (DTN) Time (Time Between Arrival at Hospital and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment) ≤ 60 Minutes Among 4.5 Hours IV-rtPA Treated Patients', 'timeFrame': 'From 2007 to 2017, up to 10 years before this study started.', 'description': 'The percentage of patients with door to needle (DTN) time (time between arrival at hospital and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment) ≤ 60 minutes among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported.'}, {'measure': 'Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients', 'timeFrame': 'From symptom onset until arrival at the hospital, up to 210 minutes.', 'description': 'Time between symptom onset and arrival at hospital among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported'}, {'measure': 'Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients', 'timeFrame': 'From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes.', 'description': 'Time between symptom onset and the administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) treatment among patients who were treated with Intravenous Recombinant Plasminogen Activator (IV-rtPA) within 4.5 hours since symptom onset was reported'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The present study is to be conducted based on the AIS patient data collected from CNSR I, II, and III.\n\nThe primary objectives are:\n\n* To investigate the temporal changes in the proportion of intravenous recombinant plasminogen activator (IV rtPA) treatment from 2007 to 2017 among Intravenous Thrombolytics (IVT) eligible patients (patient groups B and B') and overall AIS patients (patient group A) in China;\n* To investigate the temporal changes in IV rtPA treatment time intervals from 2007 to 2017 among IV rtPA treated patients (patient groups C and C') in China.\n\nThe secondary objectives are:\n\n\\- To describe the demographic and clinical characteristics of the IV rtPA treated patients (patient groups C and C'), IVT eligible patients (patient groups B and B') and the overall AIS patients (patient group A) from 2007 to 2017 from the CNSR I to III."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "All eligible patients from the CNSR I to III will be included. Patient groups include the overall AIS patients (patient group A), IVT eligible patients (patient groups B and B'), and IV rtPA treated patients (patient groups C and C').", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient group A: All AIS patients\n\n * Aged 18 80 years\n * Diagnosed with AIS on admission\n* Patient groups B and B\': IVT eligible patients\n\n * Met the in- and exclusion criteria of "all AIS patients"\n * Arrived at hospital within 2 h (patient group B) or 3.5 h (patient group B\') of symptom onset\n* Patient groups C and C\': IV rtPA treated patients\n\n * Met the in- and exclusion criteria of "IVT eligible patients"\n * Treated with IV rtPA within 3 h (patient group C) or 4.5 h (patient group C\') of symptom onset\n\nExclusion Criteria:\n\n* Patient group A: All AIS patients\n\n * Missing baseline data including age and gender\n * Diagnosed with intracranial hemorrhage (ICH), Transient Ischemic Attack (TIA), subarachnoid hemorrhage (SAH), or unspecific stroke\n * Arrived at hospital after 7 days of symptom onset\n* Patient groups B and B\': IVT eligible patients\n\n * Missing key data including:\n\n i. symptom onset time (or last known well time) ii. hospital arrival time iii. whether received IVT treatment or not iv. the time of IVT treatment\n * Documented IVT absolute contraindications, according to the case report form (CRF) for each wave of CNSR\n* Patient groups C and C\': IV rtPA treated patients\n\n * Not received IVT\n * Received IVT other than rtPA\n * Treated with IV rtPA after 3 h (patient group C) or 4.5 h (patient group C\') of symptom onset\n * Received additional treatments with intra arterial reperfusion or experimental therapies'}, 'identificationModule': {'nctId': 'NCT04290494', 'briefTitle': 'Temporal Trends of Thrombolysis Treatment in Chinese Acute Ischemic Stroke (AIS) Patients From 2007-2017: Analysis of China National Stroke Registry (CNSR) I, II, and III; CTP-Draft Review Performed;', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Temporal Trends of Thrombolysis Treatment in Chinese Acute Ischemic Stroke (AIS) Patients From 2007 2017: Analysis of China National Stroke Registry (CNSR) I, II, and III', 'orgStudyIdInfo': {'id': '0135-0343'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CNSR I (2007 to 2008)', 'description': "For this group following patients will be analysed:\n\nThe overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A)\n\nThereof: IVT eligible patients:\n\nAIS patients who arrived at hospital within 2 hours (patient group B) and 3.5 hours (patient group B') of symptom onset and with no documented absolute contraindications to IVT treatment\n\nThereof: IV rtPA treated patients:\n\nIVT eligible patients who arrived at hospital within 2 hours of symptom onset and received IV rtPA within 3 hours of symptom onset (patient group C) and those who arrived at hospital within 3.5 hours of symptom onset and received IV rtPA within 4.5 hours of symptom onset (patient group C')", 'interventionNames': ['Drug: IV rtPA (intravenous recombinant plasminogen activator)']}, {'label': 'CNSR II (2012 to 2013)', 'description': "For this group following patients will be analysed:\n\nThe overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A)\n\nThereof: IVT eligible patients:\n\nAIS patients who arrived at hospital within 2 hours (patient group B) and 3.5 hours (patient group B') of symptom onset and with no documented absolute contraindications to IVT treatment\n\nThereof: IV rtPA treated patients:\n\nIVT eligible patients who arrived at hospital within 2 hours of symptom onset and received IV rtPA within 3 hours of symptom onset (patient group C) and those who arrived at hospital within 3.5 hours of symptom onset and received IV rtPA within 4.5 hours of symptom onset (patient group C')", 'interventionNames': ['Drug: IV rtPA (intravenous recombinant plasminogen activator)']}, {'label': 'CNSR III (2015 to 2017)', 'description': "For this group following patients will be analysed:\n\nThe overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A)\n\nThereof: IVT eligible patients:\n\nAIS patients who arrived at hospital within 2 hours (patient group B) and 3.5 hours (patient group B') of symptom onset and with no documented absolute contraindications to IVT treatment\n\nThereof: IV rtPA treated patients:\n\nIVT eligible patients who arrived at hospital within 2 hours of symptom onset and received IV rtPA within 3 hours of symptom onset (patient group C) and those who arrived at hospital within 3.5 hours of symptom onset and received IV rtPA within 4.5 hours of symptom onset (patient group C')", 'interventionNames': ['Drug: IV rtPA (intravenous recombinant plasminogen activator)']}], 'interventions': [{'name': 'IV rtPA (intravenous recombinant plasminogen activator)', 'type': 'DRUG', 'description': 'intravenous injection', 'armGroupLabels': ['CNSR I (2007 to 2008)', 'CNSR II (2012 to 2013)', 'CNSR III (2015 to 2017)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'url': 'https://trials.boehringer-ingelheim.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.', 'ipdSharing': 'YES', 'description': 'After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial\\_results/clinical\\_submission\\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nAlso, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.\n\nThe data shared are the raw clinical study data sets.', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}