Phase 3
N=1,489
A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04915729 ↗Enrolled (actual)
1,489
Serious AEs
15.7%
Results posted
Dec 2024
Primary outcome: Primary: Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 — 72.7; 70.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tenecteplase (Drug); alteplase (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 |
72.7; 70.3 | — |
| 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 |
48.0; 45.0 | 0.2412 |
| SECONDARY Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 |
80.9; 79.9 | 0.7480 |
| SECONDARY Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score |
-3.47; -3.02 | 0.3511 |
| SECONDARY Distribution of Modified Rankin Scale (mRS) |
40.3; 40.5; 30.1; 28.2; 7.8; 9.4 | 0.4806 |
| SECONDARY Percentage of Participants With Barthel Index Score ≥95 |
75.7; 73.9 | 0.5116 |
| SECONDARY Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period |
1.2; 1.2 | 1.000 |
| SECONDARY Percentage of Participants Who Died by Day 90 |
4.6; 5.8 | 0.303 |
| SECONDARY Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6 |
6.8; 7.8 | 0.6345 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years old
- Diagnosis of ischaemic stroke with a measurable neurological deficit on National Institutes of Health Stroke Scale (NIHSS) (0 1.7 or Prothrombin time (PT)>15 seconds (s)) or current use of novel oral anticoagulants (i.e. dabigitran, rivaroxiban, or apixiban) with prolongation of activated partial thromboplastin time (aPTT) and/or PT above the upper limit of the local laboratory reference range
- Platelet count of below 100, 000/mm3 at screening
- Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
- Recent traumatic external heart massage, obstetrical delivery, or recent puncture of a non-compressive blood-vessel (e.g. subclavian or jugular vein puncture) , within the past 10 days
- Known history of suspected intracranial haemorrhage or suspected subarachnoid haemorrhage from aneurysm
- Neoplasm with increased haemorrhagic risk
- Documented ulcerative gastrointestinal disease during the last 3 m, oesophageal varices, arterial aneurysm, or arterial/venous malformations
- Any known disorder associated with a significant increased risk of bleeding
- Bacterial endocarditis or pericarditis at screening
- Acute pancreatitis at screening
- Significant trauma or major surgery (according to the investigator's assessment) in the past 3 m
- Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere)
- Severe uncontrolled arterial hypertension, e.g. systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT04915729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.