ArticleStroke (Hoboken, N.J.)2025
Intravenous Tenecteplase Compared With Alteplase for Acute Ischemic Stroke in Canada (AcT): Bridging the Gap From Academia to Regulatory Approval.
Article in Stroke (Hoboken, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Calibrated non-inferiority margin: a new pragmatic method to account for population shift in stroke trials.European stroke journal · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: In the AcT (Alteplase compared to Tenecteplase) trial, tenecteplase (0.25 mg/kg) was non-inferior to alteplase (0.9 mg/kg) for efficacy, and similar in terms of safety in patients with acute ischemic stroke presenting within 4.5 hours of stroke symptom onset. Additional analyses were required to support regulatory approval. Methods: Individual patient data from the AcT study were independently re-analyzed to confirm the robustness of the primary results; adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use reporting guidelines; and fulfill regulatory requirements, such as re-analysis to account for known effect modifiers of thrombolytic therapy and investigation of potential bias at randomization. These data were part of the submission to the European Medicines Agency. Results: The primary endpoint results from AcT were found to be reproducible, robust, not a chance finding, and without bias, confirming that tenecteplase was non-inferior to alteplase and significantly superior to control. The pharmacologic effect of tenecteplase in relation to sex, age, National Institutes of Health Stroke Scale score (disease severity) at baseline, and onset to treatment time was very similar to the pharmacologic effect of alteplase. Similar event rates for symptomatic intracerebral hemorrhage and death were observed for both groups. In January 2024, tenecteplase was approved for the treatment of acute ischemic stroke in Europe. Conclusion: Regulatory agencies require specific analyses in order to assess potential bias. Successful customization and extended re-analysis of data from AcT to meet regulatory requirements and adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use reporting guidelines demonstrate that it is possible to bridge the gap between academia and regulatory approval.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.