18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1Primary· 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.
Group
Value
95% CI
Tenecteplase Treatment Group
72.7
Alteplase Active Control Group
70.3
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 BaselineSecondary· 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.
Group
Value
95% CI
Tenecteplase Treatment Group
48.0
Alteplase Active Control Group
45.0
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2Secondary· 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.
Group
Value
95% CI
Tenecteplase Treatment Group
80.9
Alteplase Active Control Group
79.9
Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) ScoreSecondary· 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.
Cha
Group
Value
95% CI
Tenecteplase Treatment Group
-3.47
± 0.34
Alteplase Active Control Group
-3.02
± 0.34
Distribution of Modified Rankin Scale (mRS)Secondary· 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.
mRS score = 0
Group
Value
95% CI
Tenecteplase Treatment Group
40.3
Alteplase Active Control Group
40.5
mRS score = 1
Group
Value
95% CI
Tenecteplase Treatment Group
30.1
Alteplase Active Control Group
28.2
mRS score = 2
Group
Value
95% CI
Tenecteplase Treatment Group
7.8
Alteplase Active Control Group
9.4
mRS score = 3
Group
Value
95% CI
Tenecteplase Treatment Group
6.7
Alteplase Active Control Group
5.5
mRS score = 4
Group
Value
95% CI
Tenecteplase Treatment Group
4.8
Alteplase Active Control Group
6.4
mRS score = 5
Group
Value
95% CI
Tenecteplase Treatment Group
1.9
Alteplase Active Control Group
1.6
mRS score = 6
Group
Value
95% CI
Tenecteplase Treatment Group
4.6
Alteplase Active Control Group
6.0
missing
Group
Value
95% CI
Tenecteplase Treatment Group
3.8
Alteplase Active Control Group
2.3
Percentage of Participants With Barthel Index Score ≥95Secondary· 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.
Group
Value
95% CI
Tenecteplase Treatment Group
75.7
Alteplase Active Control Group
73.9
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment PeriodSecondary· 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.
Group
Value
95% CI
Tenecteplase Treatment Group
1.2
Alteplase Active Control Group
1.2
Percentage of Participants Who Died by Day 90Secondary· up to 90 days
Percentage of participants who died by day 90 is presented. Percentages are rounded to the nearest digits.
Group
Value
95% CI
Tenecteplase Treatment Group
4.6
Alteplase Active Control Group
5.8
Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6Secondary· 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.
Group
Value
95% CI
Tenecteplase Treatment Group
6.8
Alteplase Active Control Group
7.8
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is open to Chinese adults who had an ischaemic stroke, which means that blood vessels in the brain are blocked. To resolve blood clots, people in the study get either tenecteplase or alteplase within 4 hours and 30 minutes after stroke. The purpose of this study is to compare how tenecteplase and alteplase improve peoples' recovering of physical activity. Alteplase is standard of care. Tenecteplase is a modified variant of alteplase that is easier to administer and is approved to treat heart attack. This study is to find out whether tenecteplase is as good as alteplase in people with ischaemic stroke.
Participants are equally put into 2 treatment groups by chance. Participants in one group get tenecteplase as a single injection into a vein. Participants in the other group get alteplase as an injection into a vein (10% of the dose) and the remainder as an infusion over 1 hour.
Participants are in the study for about 3 months. They are in the hospital for the first week after treatment. Then they visit the study site 1 and 3 months after treatment. At these visits, peoples' ability to independently carry out daily activities is assessed. Scores for physical activity are compared between both treatment groups. The doctors also regularly check the general health of the participants.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07271342 — Observational RegIstry of Effectiveness and Safety of teNecTeplase in reAl worLd Settings in China
· recruiting
NCT06949228 — Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
· Phase 2, PHASE3
· recruiting
NCT06498323 — Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT
· Phase 4
· recruiting
NCT00623623 — STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 10 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04915729.