drugset / Trial / NCT02930837

Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset

NCT02930837 ↗

Phase 3 Completed 120 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours after onset of stroke symptoms in Chinese patients with acute ischemic stroke

Timeline

Start
2016-11-15
Primary completion
2017-12-11
Completion
2017-12-11

Outcome

Met primary endpoint

paper The percentage of patients with a favourable outcome was 63.3% (95% CI 54.4 to 71.4), significantly higher than the predefined threshold (p<0.0001). PMID 32467323 ↗

Drugs

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

Indications