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The present study is to be conducted based on the AIS patient data collected from CNSR I, II, and III.
The primary objectives are:
The secondary objectives are:
- 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNSR I (2007 to 2008) | For this group following patients will be analysed: The overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A) Thereof: IVT eligible patients: AIS 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 Thereof: IV rtPA treated patients: IVT 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') |
| |
| CNSR II (2012 to 2013) | For this group following patients will be analysed: The overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A) Thereof: IVT eligible patients: AIS 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 Thereof: IV rtPA treated patients: IVT 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') |
| |
| CNSR III (2015 to 2017) | For this group following patients will be analysed: The overall AIS patients aged 18 to 80 years who arrived at hospital within 7 days of symptom onset (Patient group A) Thereof: IVT eligible patients: AIS 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 Thereof: IV rtPA treated patients: IVT 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') |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV rtPA (intravenous recombinant plasminogen activator) | Drug | intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From 2007 to 2017, up to 10 years before this study started. |
| 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 | 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. | From 2007 to 2017, up to 10 years before this study started. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Patient group A: All AIS patients
Patient groups B and B': IVT eligible patients
Patient groups C and C': IV rtPA treated patients
Exclusion Criteria:
Patient group A: All AIS patients
Patient groups B and B': IVT eligible patients
Missing key data including:
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
Documented IVT absolute contraindications, according to the case report form (CRF) for each wave of CNSR
Patient groups C and C': IV rtPA treated patients
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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').
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41673614 | Derived | Li L, Pan Y, Yan H, Wu Y, Sun F, Shi X, Zhou Y, Wang Y. Predictive role of baseline serum creatinine-to-cystatin C ratio for renal dysfunction incidence in patients with acute ischemic stroke. BMC Nephrol. 2026 Feb 11;27(1):172. doi: 10.1186/s12882-026-04779-3. |
| Label | URL |
|---|---|
| Related Info | View source |
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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".
Also, 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.
The data shared are the raw clinical study data sets.
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.
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'.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | China National Stroke Registry (CNSR) I (2007 to 2008) | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2020 | Nov 3, 2021 |
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|
| From 2007 to 2017, up to 10 years before this study started. |
| 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 | 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. | From 2007 to 2017, up to 10 years before this study started. |
| 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 | 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. | From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 170 minutes. |
| 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 | 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. | From 2007 to 2017, up to 10 years before this study started. |
| Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients | 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. | From symptom onset until arrival at the hospital, up to 120 minutes. |
| Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients | 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. | From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes. |
| 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 | 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. | From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 minutes. |
| 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 | 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. | From 2007 to 2017, up to 10 years before this study started. |
| Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients | 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 | From symptom onset until arrival at the hospital, up to 210 minutes. |
| Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients | 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 | From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes. |
| China National Stroke Registry (CNSR) II (2012 to 2013) |
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. |
| FG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | China National Stroke Registry (CNSR) I (2007 to 2008) | 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. |
| BG001 | China National Stroke Registry (CNSR) II (2012 to 2013) | 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. |
| BG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2007 to 2017, up to 10 years before this study started. |
|
|
| |||||||||||||||||||||||||||||||
| Primary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2007 to 2017, up to 10 years before this study started. |
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2007 to 2017, up to 10 years before this study started. |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2007 to 2017, up to 10 years before this study started. |
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| Secondary | 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 | 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. | 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. | Posted | Median | Inter-Quartile Range | minutes | From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 170 minutes. |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2007 to 2017, up to 10 years before this study started. |
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| Secondary | Time Between Symptom Onset and Arrival at Hospital Among 3 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients | 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. | 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. | Posted | Median | Inter-Quartile Range | minutes | From symptom onset until arrival at the hospital, up to 120 minutes. |
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| Secondary | Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 3 Hours IV-rtPA Treated Patients | 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. | 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. | Posted | Median | Inter-Quartile Range | minutes | From symptom onset until administration of Intravenous Recombinant Plasminogen Activator, up to 180 minutes. |
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| Secondary | 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 | 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. | 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. | Posted | Median | Inter-Quartile Range | minutes | From arrival at the hospital until the administration of Intravenous Recombinant Plasminogen Activator, up to 247 minutes. |
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2007 to 2017, up to 10 years before this study started. |
| |||||||||||||||||||||||||||||||||
| Secondary | Time Between Symptom Onset and Arrival at Hospital Among 4.5 Hours Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treated Patients | 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 | 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. | Posted | Median | Inter-Quartile Range | minutes | From symptom onset until arrival at the hospital, up to 210 minutes. |
| |||||||||||||||||||||||||||||||||
| Secondary | Time Between Symptom Onset and the Administration of Intravenous Recombinant Plasminogen Activator (IV-rtPA) Treatment Among 4.5 Hours IV-rtPA Treated Patients | 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 | 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. | Posted | Median | Inter-Quartile Range | minutes | From symptom onset until the administration of Intravenous Recombinant Plasminogen Activator, up to 270 minutes. |
|
Adverse event information was not collected for this study.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | China National Stroke Registry (CNSR) I (2007 to 2008) | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | China National Stroke Registry (CNSR) II (2012 to 2013) | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.
Investigators 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.
BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 3, 2020 | Nov 3, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
|
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
|
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
|
|
| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
|
|
| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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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.
| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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| OG002 | China National Stroke Registry (CNSR) III (2015 to 2017) | 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. |
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