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The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV rt-PA cohort | Patients who received IV rt-PA within 4.5 hours of symptom onset |
| |
| Non-reperfusion cohort | Patients who arrived or were admitted to the hospital within4.5 hours of symptom onset and did not receive any reperfusion treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rt-PA | Drug | Recombinant Tissue Plasminogen Activator |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6) | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
| Up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
|
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Inclusion criteria:
Exclusion criteria:
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In this study, AIS patient data from 80 stroke centres in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from January 2017 to March 2020 will be used.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim (China) Investment Co., ltd. | Shanghai | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40772407 | Derived | Xue R, Gong X, Huang Y, Zhong W, Jin H, Chen Z, Chen Y, Yan S, Hu H, Yuan C, Lou M. One-Year Outcomes After Intravenous Recombinant Tissue Plasminogen Activator for Ischemic Stroke: A Real-World Study. CNS Neurosci Ther. 2025 Aug;31(8):e70543. doi: 10.1111/cns.70543. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Between January 2017 and March 2020, 98,330 AIS patients were registered in the ZSQCC platform. A total of 12,551 patients were included in the study, with 6,494 of them matched 1:1 (3,247 in the IV Rt-PA Cohort and 3,247 in the Non-reperfusion Cohort) based on baseline characteristics using the propensity score matching (PSM) method. Only the propensity score-matched patients as described here were used for the data analyses.
This non-interventional study (NIS) based on existing data collected from the Zhejiang Stroke Quality Control Centre (ZSQCC) platform of Acute Ischaemic Stroke (AIS) patients aged ≥18 years in China aimed to compare the 1-year mortality of AIS patients treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset versus those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive reperfusion treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Rt-PA Cohort | Patients who received IV rt-PA within 4.5 hours of symptom onset |
| FG001 | Non-reperfusion Cohort | Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients >= 18 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Rt-PA Cohort | Patients who received IV rt-PA within 4.5 hours of symptom onset |
| BG001 | Non-reperfusion Cohort | Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6) | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
| Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients >= 18 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 1 year. |
All-Cause-mortality: From the patient registration in the ZSQCC platform (between January 2017 and March 2020) to 1-year follow-up, up to 1 year.
This is a non-interventional study (NIS) based on existing data from the Zhejiang Stroke Quality Control Centre (ZSQCC) platform. No adverse events were collected on an individual case level. Serious Adverse Events and Other Adverse Events are not collected in the database. "0" total Number of Participants at Risk means "Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".
All-Cause Mortality is an outcome of this study and thus additionally reported below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Rt-PA Cohort | Patients who received IV rt-PA within 4.5 hours of symptom onset |
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This was a non-interventional study (NIS) based on existing data, although Propensity Score Matching (PSM) was used, we cannot rule out the influence of other unmeasured confounding factors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 018002430127 | clintriage.rdg@boehringer-ingelheim.com |
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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 | Sep 2, 2021 | Nov 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2021 | Nov 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Up to 1 year. |
| Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
| Up to 1 year. |
| Percentage of Patients With mRS Score 5 to 6 at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
| Up to 1 year. |
| Distribution of mRS Score at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Clinicians give the mRS score per the clinical diagnosis/symptom to the patient. There is no calculation for this endpoint or each individual components. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. | Up to 1 year. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | IV Rt-PA Cohort | Patients who received IV rt-PA within 4.5 hours of symptom onset |
| OG001 | Non-reperfusion Cohort | Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment |
|
|
|
| Secondary | Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
| Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients >= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 1 year. |
|
|
|
|
| Secondary | Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
| Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients >= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1 year. |
|
|
|
|
| Secondary | Percentage of Patients With mRS Score 5 to 6 at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
| Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients >= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1 year. |
|
|
|
|
| Secondary | Distribution of mRS Score at 1 Year | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Clinicians give the mRS score per the clinical diagnosis/symptom to the patient. There is no calculation for this endpoint or each individual components. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. | Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients >= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis. | Posted | Mean | Standard Deviation | Score on a scale | Up to 1 year. |
|
|
|
|
| 360 |
| 3,247 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Non-reperfusion Cohort | Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment | 396 | 3,247 | 0 | 0 | 0 | 0 |
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.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |