Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study.

ABSTRACT:

Background

Tenecteplase, a bioengineered variant of alteplase, is a new alternative thrombolytic agent. The ORIGINAL study aims to evaluate the efficacy and safety of tenecteplase versus standard care in Chinese patients with acute ischemic stroke within 4.5 hours of symptom onset.

Methods

This is a multicenter phase III study that employs a randomized (1:1), active-controlled, parallel-group, prospective, open-label, blinded-end point design. Adult participants (aged ≥18 years) with acute ischemic stroke who are eligible for intravenous thrombolysis within 4.5 hours of symptom onset according to current guideline recommendations are recruited from ≈55 neurology clinics/stroke centers throughout China.

Results

The primary objective of the ORIGINAL study is to demonstr

SUBMITTER: Meng X 

PROVIDER: S-EPMC12778536 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature