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The objective of the study is to find out the in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase) | Group 1: Acute ischemic stroke (AIS) patients aged >80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
| |
| Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase) | Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
| |
| Acute ischemic stroke (AIS) patients aged >80 years without thrombolysis treatment | Group 3: Acute ischemic stroke (AIS) patients aged >80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. | ||
| Acute ischemic stroke (AIS) patients aged 18 to 80 years without thrombolysis treatment | Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rt-PA | Drug | Intravenous recombinant tissue plasminogen activator (IV rt-PA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA). | Up to 100 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Hemorrhagic Stroke During Hospitalization | Percentage of patients with hemorrhagic stroke during hospitalization. | Up to 100 days. |
| Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Acute ischemic stroke (AIS) patients who were treated with Intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) or did not receive thrombolysis treatment within 4.5 hours of symptom onset, aged ≥18 years old.
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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 |
|---|---|---|---|
| 39477171 | Derived | Jiang Y, Wang C, Gu H, Zhou Q, Jiang Y, Li Z, Wang Y. In-hospital outcomes of intravenous recombinant tissue plasminogen activator treatment for acute ischemic stroke in patients aged >80 years: Findings from the Chinese Stroke Center Alliance. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108102. doi: 10.1016/j.jstrokecerebrovasdis.2024.108102. Epub 2024 Oct 28. |
| 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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All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
In this study the Chinese Stroke Centre Alliance (CSCA) data was used to describe the in-hospital clinical outcomes regarding safety and effectiveness for acute ischemic stroke (AIS) patients who were treated with intravenous recombinant tissue plasminogen activator (IV rt-PA) within 4.5 hours of symptom onset, aged above 80 years, as well as between 18 and 80 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Group 1: Acute ischemic stroke (AIS) patients aged >80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
| FG001 | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
| FG002 | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | Group 3: Acute ischemic stroke (AIS) patients aged >80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. |
| FG003 | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Group 1: Acute ischemic stroke (AIS) patients aged >80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
| BG001 | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) |
| 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 During Hospitalization of Acute Ischemic Stroke (AIS) Patients | All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA). | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase). Endpoint was planned to only include Group 1 and 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 100 days. |
|
Adverse event information was not applicable for this study. All-cause mortality was only collected and reported for group 1 and group 2 for up to 100 days.
This is a non-interventional study using electronic health care records, with data retrieved from the Chinese Stroke Centre Alliance (CSCA). No adverse events were collected on an individual case level. All-cause mortality was only collected and reported for group 1 and group 2.
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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 | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Group 1: Acute ischemic stroke (AIS) patients aged >80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
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Hospital participation in the Chinese Stroke Centre Alliance (CSCA) was voluntary. To avoid selection bias, all patients were included without sampling when dataset was extracted. The larger sample size and broad geological distribution increased representativeness.
Data collected by hospitals were not audited by external chart review. Data reliability depends on training for data abstractors and automated checks to identify erroneous, illogical data entries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 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 22, 2021 | Mar 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2022 | Nov 13, 2024 | 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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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment. |
| Up to 24 hours. |
| Modified Rankin Score (mRS) at Discharge | The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death. | Up to 100 days. |
| Number of Patients With Stroke Recurrence During Hospitalization | Number of patients with stroke recurrence during hospitalization. | Up to 100 days. |
| Length of Hospitalization | Length of hospitalization. | Up to 100 days. |
| Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset | Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset. | Up to 4.5 hours. |
| Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission) | Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission). | Up to 4.5 hours. |
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
| BG002 | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | Group 3: Acute ischemic stroke (AIS) patients aged >80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. |
| BG003 | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. |
| BG004 | 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. | Count of Participants | Participants |
|
| OG001 | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. |
|
|
| Secondary | Percentage of Patients With Hemorrhagic Stroke During Hospitalization | Percentage of patients with hemorrhagic stroke during hospitalization. | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Up to 100 days. |
|
|
|
| Secondary | Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment. | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2. Only patients with collected NIHSS scores were included in the endpoint. | Posted | Mean | Standard Deviation | Score on a scale | Up to 24 hours. |
|
|
|
| Secondary | Modified Rankin Score (mRS) at Discharge | The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death. | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Subjects without a discharge mRS score were excluded. Endpoint was planned to only include Group 1 and 2. | Posted | Count of Participants | Participants | Up to 100 days. |
|
|
|
| Secondary | Number of Patients With Stroke Recurrence During Hospitalization | Number of patients with stroke recurrence during hospitalization. | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2. | Posted | Count of Participants | Participants | Up to 100 days. |
|
|
|
| Secondary | Length of Hospitalization | Length of hospitalization. | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2. | Posted | Mean | Standard Deviation | days | Up to 100 days. |
|
|
|
| Secondary | Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset | Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset. | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 4.5 hours. |
|
|
|
| Secondary | Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission) | Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission). | Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission and who arrived to the hospital within 3.5 hours of symptom onset and who were eligible for rt-PA treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 4.5 hours. |
|
|
|
| 88 |
| 3,332 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset. | 211 | 28,086 | 0 | 0 | 0 | 0 |
| EG002 | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | Group 3: Acute ischemic stroke (AIS) patients aged >80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| Male |
|
| mRS score 2 |
|
| mRS score 3 |
|
| mRS score 4 |
|
| mRS score 5 |
|
| mRS score 6 |
|