Trial · NCT05401149
Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients
NCT05401149, Completed, Boehringer Ingelheim; results first posted 2024-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients. Trials, record NCT05401149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05401149
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients
- NCT number
- NCT05401149
- Status
- Completed
- Enrollment
- 3,058 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Stroke
- Interventions
- rt-PA
- First posted
- 2022-06-02
- Last updated
- 2024-10-17
- Results first posted
- 2024-10-17
- Limitations and caveats
- According to Boehringer Ingelheim's internal policy, no document date is required in the title page of the Statistical and Epidemiological Analysis Plan
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | Percentage of patients with favourable outcome (modified Rankin Scale (mRS) 0-1) 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. 1. \- No significant disability. 2. \- Slight disability. 3. \- Moderate disability. 4. \- Moderately severe disability. 5. \- Severe disability. 6. \- Dead. Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission. |
| Secondary | Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation | Up to 3 months | Percentage of patients with any intracranial haemorrhage (ICH) during hospitalisation. Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission. |
| Secondary | All-cause Mortality During Hospitalisation | Up to 3 months | All-cause mortality during hospitalisation. Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission. |
| Secondary | Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | Percentage of patients with independence (modified Rankin Scale (mRS) 0-2) 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. 1. \- No significant disability. 2. \- Slight disability. 3. \- Moderate disability. 4. \- Moderately severe disability. 5. \- Severe disability. 6. \- Dead. Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission. |
| Secondary | Distribution of Modified Rankin Scale (mRS) Score at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | Distribution of modified Rankin Scale (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. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms. 1. \- No significant disability. 2. \- Slight disability. 3. \- Moderate disability. 4. \- Moderately severe disability. 5. \- Severe disability. 6. \- Dead. Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission. |
| Secondary | All-cause Mortality at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | All-cause mortality at 1 year. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1), clinical outcomes and baseline characteristics were compared between the matched cohorts. Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation | Up to 3 months | Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020. | Percentage of Participants | NUMBER |
| SECONDARY | All-cause Mortality During Hospitalisation | Up to 3 months | Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020. | Percentage of Participants | NUMBER |
| SECONDARY | Distribution of Modified Rankin Scale (mRS) Score at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020. | Units on a scale | MEAN |
| SECONDARY | All-cause Mortality at 1 Year | Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study). | Among PSM cohort (1560 patients), 120 patients (41 in IV rt-PA group; 79 in non-reperfusion therapy group) were excluded from the analysis due to missing date of death.~To ensure that each matching pair has one patient from IV rt-PA group and one patient from non-reperfusion therapy group at the same time further 118 patients (78 in IV rt-PA group; 40 in non-reperfusion therapy group) were excluded. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year | IV Rt-PA Cohort | 27.7 | 95% Confidence Interval 24.6 to 30.8 | Percentage of Participants | |
| Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year | Non-reperfusion Cohort | 23.8 | 95% Confidence Interval 20.9 to 26.8 | Percentage of Participants | |
| Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation | IV Rt-PA Cohort | 13.7 | 95% Confidence Interval 11.3 to 16.1 | Percentage of Participants | |
| Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation | Non-reperfusion Cohort | 10.8 | 95% Confidence Interval 8.6 to 12.9 | Percentage of Participants | |
| All-cause Mortality During Hospitalisation | IV Rt-PA Cohort | 4.5 | 95% Confidence Interval 3.0 to 5.9 | Percentage of Participants | |
| All-cause Mortality During Hospitalisation | Non-reperfusion Cohort | 2.8 | 95% Confidence Interval 1.7 to 4.0 | Percentage of Participants | |
| Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year | IV Rt-PA Cohort | 37.3 | 95% Confidence Interval 33.9 to 40.7 | Percentage of Participants | |
| Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year | Non-reperfusion Cohort | 33.7 | 95% Confidence Interval 30.4 to 37.0 | Percentage of Participants | |
| Distribution of Modified Rankin Scale (mRS) Score at 1 Year | IV Rt-PA Cohort | 3.5 | Standard Deviation 2.4 | Units on a scale | |
| Distribution of Modified Rankin Scale (mRS) Score at 1 Year | Non-reperfusion Cohort | 3.7 | Standard Deviation 2.3 | Units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV Rt-PA Cohort | 780 | |
| Overall Study | STARTED | Non-reperfusion Cohort | 780 | |
| Overall Study | COMPLETED | IV Rt-PA Cohort | 780 | |
| Overall Study | COMPLETED | Non-reperfusion Cohort | 780 | |
| Overall Study | NOT COMPLETED | IV Rt-PA Cohort | 0 | |
| Overall Study | NOT COMPLETED | Non-reperfusion Cohort | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Rt-PA Cohort | 308 | 780 |
| Total, all-cause mortality | Non-reperfusion Cohort | 303 | 780 |
| Total, other adverse events | IV Rt-PA Cohort | 0 | 0 |
| Total, other adverse events | Non-reperfusion Cohort | 0 | 0 |
| Total, serious adverse events | IV Rt-PA Cohort | 0 | 0 |
| Total, serious adverse events | Non-reperfusion Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40312065 | 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 |
|---|
| IV Rt-PA Cohort vs Non-reperfusion Cohort: deaths from any cause |
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/NCT05401149
GET https://conductscience.org/api/trials/v1/NCT05401149/registered