Trial · NCT05395351
Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
NCT05395351, Completed, Boehringer Ingelheim; results first posted 2024-12-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization. Trials, record NCT05395351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05395351
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
- NCT number
- NCT05395351
- Status
- Completed
- Enrollment
- 113,035 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Stroke
- Interventions
- rt-PA
- First posted
- 2022-05-27
- Last updated
- 2024-12-20
- Results first posted
- 2024-12-20
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | Up to 100 days. | All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA). |
| Secondary | Percentage of Patients With Hemorrhagic Stroke During Hospitalization | Up to 100 days. | Percentage of patients with hemorrhagic stroke during hospitalization. |
| Secondary | Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | Up to 24 hours. | 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. |
| Secondary | Modified Rankin Score (mRS) at Discharge | Up to 100 days. | 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. |
| Secondary | Number of Patients With Stroke Recurrence During Hospitalization | Up to 100 days. | Number of patients with stroke recurrence during hospitalization. |
| Secondary | Length of Hospitalization | Up to 100 days. | Length of hospitalization. |
| 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 | Up to 4.5 hours. | 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. |
| 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) | 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | Up to 100 days. | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Hemorrhagic Stroke During Hospitalization | Up to 100 days. | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | Up to 24 hours. | 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. | Score on a scale | MEAN |
| SECONDARY | Modified Rankin Score (mRS) at Discharge | Up to 100 days. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Stroke Recurrence During Hospitalization | Up to 100 days. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Hospitalization | Up to 100 days. | 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. | days | MEAN |
| 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 | Up to 4.5 hours. | 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. | Percentage of participants | NUMBER |
| 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) | Up to 4.5 hours. | 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. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 2.6 | 95% Confidence Interval 2.1 to 3.2 | Percentage of participants | |
| All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 0.8 | 95% Confidence Interval 0.7 to 0.9 | Percentage of participants | |
| Percentage of Patients With Hemorrhagic Stroke During Hospitalization | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 6.7 | 95% Confidence Interval 5.8 to 7.5 | Percentage of subjects | |
| Percentage of Patients With Hemorrhagic Stroke During Hospitalization | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 3.1 | 95% Confidence Interval 2.9 to 3.3 | Percentage of subjects | |
| Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 2.8 | Standard Deviation 5.0 | Score on a scale | |
| Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 2.5 | Standard Deviation 4.3 | Score on a scale | |
| Modified Rankin Score (mRS) at Discharge | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | mRS score 0 | 383 | Participants | |
| Modified Rankin Score (mRS) at Discharge | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | mRS score 0 | 5447 | Participants | |
| Modified Rankin Score (mRS) at Discharge | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | mRS score 1 | 612 | Participants | |
| Modified Rankin Score (mRS) at Discharge | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | mRS score 1 | 6427 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 3,332 | |
| Overall Study | STARTED | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 28,086 | |
| Overall Study | STARTED | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | 12,533 | |
| Overall Study | STARTED | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | 69,084 | |
| Overall Study | COMPLETED | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 3,332 | |
| Overall Study | COMPLETED | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 28,086 | |
| Overall Study | COMPLETED | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | 12,533 | |
| Overall Study | COMPLETED | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | 69,084 | |
| Overall Study | NOT COMPLETED | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 0 | |
| Overall Study | NOT COMPLETED | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 88 | 3,332 |
| Total, all-cause mortality | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 211 | 28,086 |
| Total, all-cause mortality | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | 0 | 0 |
| Total, all-cause mortality | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | 0 | 0 |
| Total, other adverse events | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 0 | 0 |
| Total, other adverse events | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 0 | 0 |
| Total, other adverse events | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | 0 | 0 |
| Total, other adverse events | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | 0 | 0 |
| Total, serious adverse events | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 0 | 0 |
| Total, serious adverse events | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39477171 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) vs Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase): Number of Patients With Stroke Recurrence During Hospitalization |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05395351
GET https://conductscience.org/api/trials/v1/NCT05395351/results?page=2