Intravenous Tenecteplase Compared With Alteplase for Acute Ischemic Stroke in Canada (AcT): Bridging the Gap From Academia to Regulatory Approval
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.
Authors
- Thierry Danays (ORCID: https://orcid.org/0000-0002-0594-6490)
- Brian H Buck (ORCID: https://orcid.org/0000-0002-7984-6062)
- Mohammed Almekhlafi (ORCID: https://orcid.org/0000-0001-9550-8197)
- Rick Swartz (ORCID: https://orcid.org/0000-0001-6571-5531)
- Nishita Singh (ORCID: https://orcid.org/0000-0003-3647-0904)
- Alain Pagès
- Luciana Catanese (ORCID: https://orcid.org/0000-0002-8696-5211)
- Bijoy K. Menon (ORCID: https://orcid.org/0000-0002-3466-496X)
- Tolulope T. Sajobi (ORCID: https://orcid.org/0000-0002-5696-5552)
- Nuala Peter
Institutions
- Sunnybrook Health Science Centre (CA)
- Boehringer Ingelheim (Germany) (DE)
- University of Alberta (CA)
- University of Calgary (CA)
- University of Toronto (CA)
- McMaster University Medical Centre (CA)
- Health Sciences Centre (CA)
- Centre Paul Albert-Février (FR)
- Boehringer Ingelheim (China) (CN)
- Boehringer Ingelheim (Australia) (AU)
- University of Manitoba (CA)
- Hamilton Health Sciences (CA)
Publication Details
- Journal
- Stroke Vascular and Interventional Neurology
- Published
- 2025-06-07
- DOI
- https://doi.org/10.1161/svin.124.001705
- Citations
- 1
- Primary Topic
- Acute Ischemic Stroke Management
- Type
- article
- Field-Weighted Citation Impact
- 1.35