Trial · NCT04915729
A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
NCT04915729, Phase 3, Completed, Boehringer Ingelheim; results first posted 2024-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity. Trials, record NCT04915729. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04915729
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
- NCT number
- NCT04915729
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,489 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Stroke
- Interventions
- tenecteplase, alteplase
- First posted
- 2021-06-07
- Last updated
- 2024-12-10
- Results first posted
- 2024-12-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 | At Day 90±7 days | Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits. |
| Secondary | Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline | At 24 hours | Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Mild strokes (NIHSS \< 6): High likelihood of good recovery and independence, Moderate strokes (NIHSS 6-15): Variable outcomes depending on timely intervention, Severe strokes (NIHSS \> 15): Lower likelihood of recovery without significant disability and higher risk of mortality. Percentages are rounded to the nearest digits. |
| Secondary | Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 | At Day 90 | Percentage of participants with Modified Rankin Scale (mRS) score of 0-2 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits. |
| Secondary | Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score | At baseline and at Day 90 | Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Restricted maximum likelihood (REML) based MMRM approach used to compare change from baseline in NIHSS score at day 90. If patient misses visit, missing data will not be imputed. The mixed effect model will handle missing data based on a likelihood method under MAR assumption. Change in NIHSS score from baseline = overall mean + treatment + visit + baseline NIHSS + age + time to drug administration since onset of stroke symptoms + treatment by visit interaction + baseline NIHSS by visit interaction + random error. |
| Secondary | Distribution of Modified Rankin Scale (mRS) | At Day 90 | Distribution of Modified Rankin Scale (mRS) is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. |
| Secondary | Percentage of Participants With Barthel Index Score ≥95 | up to 90 days | The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome. Percentages are rounded to the nearest digits. |
| Secondary | Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period | Up to 7 days. | Percentage of participants with Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) Ⅲ definition during on-treatment period is presented. Percentages are rounded to the nearest digits. |
| Secondary | Percentage of Participants Who Died by Day 90 | up to 90 days | Percentage of participants who died by day 90 is presented. Percentages are rounded to the nearest digits. |
| Secondary | Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6 | At Day 90 | Percentage of participants with Modified Rankin Scale (mRS) score of 5 or 6 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 | At Day 90±7 days | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline | At 24 hours | Full Analysis Set (FAS), This endpoint analysis is based on observed cases, no imputation performed for patients missing NIHSS score at 24h. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 | At Day 90 | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score | At baseline and at Day 90 | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Distribution of Modified Rankin Scale (mRS) | At Day 90 | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Barthel Index Score ≥95 | up to 90 days | Full Analysis Set (FAS), No imputation was performed on patients missing Bathel Score at day 90. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period | Up to 7 days. | Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died by Day 90 | up to 90 days | Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6 | At Day 90 | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 | Tenecteplase Treatment Group | 72.7 | Percentage of participants | ||
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 | Alteplase Active Control Group | 70.3 | Percentage of participants | ||
| Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline | Tenecteplase Treatment Group | 48.0 | Percentage of participants | ||
| Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline | Alteplase Active Control Group | 45.0 | Percentage of participants | ||
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 | Tenecteplase Treatment Group | 80.9 | Percentage of participants | ||
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 | Alteplase Active Control Group | 79.9 | Percentage of participants | ||
| Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score | Tenecteplase Treatment Group | -3.47 | Standard Error 0.34 | score on a scale | |
| Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score | Alteplase Active Control Group | -3.02 | Standard Error 0.34 | score on a scale | |
| Distribution of Modified Rankin Scale (mRS) | Tenecteplase Treatment Group | mRS score = 0 | 40.3 | Percentage of participants | |
| Distribution of Modified Rankin Scale (mRS) | Alteplase Active Control Group | mRS score = 0 | 40.5 | Percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tenecteplase Treatment Group | 744 | |
| Overall Study | STARTED | Alteplase Active Control Group | 745 | |
| Overall Study | Treated | Tenecteplase Treatment Group | 733 | |
| Overall Study | Treated | Alteplase Active Control Group | 735 | |
| Overall Study | COMPLETED | Tenecteplase Treatment Group | 671 | |
| Overall Study | COMPLETED | Alteplase Active Control Group | 675 | |
| Overall Study | NOT COMPLETED | Tenecteplase Treatment Group | 73 | |
| Overall Study | NOT COMPLETED | Alteplase Active Control Group | 70 |
Source ClinicalTrials.gov
Adverse events170
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Alteplase Active Control Group | 37 | 736 | |
| other | Anaemia | Blood and lymphatic system disorders | Tenecteplase Treatment Group | 32 | 732 | |
| other | Constipation | Gastrointestinal disorders | Alteplase Active Control Group | 123 | 736 | |
| other | Constipation | Gastrointestinal disorders | Tenecteplase Treatment Group | 131 | 732 | |
| other | Gingival bleeding | Gastrointestinal disorders | Alteplase Active Control Group | 78 | 736 | |
| other | Gingival bleeding | Gastrointestinal disorders | Tenecteplase Treatment Group | 79 | 732 | |
| other | Pyrexia | General disorders | Alteplase Active Control Group | 43 | 736 | |
| other | Pyrexia | General disorders | Tenecteplase Treatment Group | 33 | 732 | |
| other | Pneumonia | Infections and infestations | Alteplase Active Control Group | 65 | 736 | |
| other | Pneumonia | Infections and infestations | Tenecteplase Treatment Group | 55 | 732 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alteplase Active Control Group | 44 | 736 |
| Total, all-cause mortality | Tenecteplase Treatment Group | 34 | 732 |
| Total, other adverse events | Alteplase Active Control Group | 347 | 736 |
| Total, other adverse events | Tenecteplase Treatment Group | 334 | 732 |
| Total, serious adverse events | Alteplase Active Control Group | 115 | 736 |
| Total, serious adverse events | Tenecteplase Treatment Group | 116 | 732 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Alteplase Active Control Group vs Tenecteplase Treatment Group: deaths from any cause | Trial comparisons |
| Alteplase Active Control Group vs Tenecteplase Treatment Group: serious adverse events | 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/NCT04915729
GET https://conductscience.org/api/trials/v1/NCT04915729/results?page=2