drugset / Trial / NCT04879615

24 Hours Treatment with Alteplase in Patients with Ischemic Stroke

NCT04879615 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

The development of intravenous thrombolysis has greatly improved the rate of recanalization and reperfusion in patients with acute ischemic stroke, increasing the proportion of patients with good outcome and reduced mortality. The guideline recommends that patients with ischemic stroke should be treated with intravenous thrombolysis within 4.5 hours. The latest meta-analysis found that ischemic stroke with onset time of 4.5-9 hours with infarction core volume \<70ml, ischemic penumbra volume \>10ml, and hypoperfusion volume / infarction core volume \>1.2 could be benefit from intravenous thrombolysis. The DAWN clinical trial has shown that patients with ischemic stroke with large vessel occlusion with onset time of 6-24 hours could be benefit from endovascular treatment after screening by multi-mode imaging. Therefore, we hypothesize that patients with ischemic stroke with onset time of 4.5-24 hours with a definite penumbra may also benefit from intravenous thrombolysis. The purpose of this study is to explore whether the patients with ischemic stroke with onset time of 4.5-24 hours can benefit from intravenous thrombolysis if they meet the standard of CT perfusion screening.

Timeline

Start
2021-06-21
Primary completion
2024-06-30
Completion
2024-09-30

Outcome

Met primary endpoint

paper The primary outcome occurred in 75 of 186 patients (40%) in the alteplase group and 49 of 186 (26%) in the control group PMID 40773205 ↗

paper (adjusted risk ratio, 1.52 [95% CI, 1.14-2.02]; P = .004; PMID 40773205 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Alteplase Protein / enzyme biologic 0.9 mg/kg Intravenous

Indications