Intravenous Tenecteplase Compared With Alteplase for Acute Ischemic Stroke in Canada (AcT): Bridging the Gap From Academia to Regulatory Approval.

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

SUBMITTER: Peter N 

PROVIDER: S-EPMC12697637 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature