CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 391 enrolled
Drug / intervention
Tenecteplase +1 moredrug
Likely dose
Tenecteplase 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06221371
NCT06221371Phase 3Completed

Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion: a Multi-center, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE), Phase 3 Trial

Beijing Tiantan Hospital·interventional·Posted Jan 24, 2024·Updated Nov 26, 2025

In Brief

A Phase 3 clinical trial evaluating Tenecteplase and direct EVT for Ischemic Stroke, Acute and 2 related conditions. Completed, enrolled 391 participants across 21 sites.

Detailed Summary

The purpose of this study is to investigate the safety and efficacy of endovascular treatment with or without preceding intravenous Tenecteplase in patients with late-window (4.5-24 hours of symptom onset) acute ischemic stroke due to middle cerebral artery (MCA) M1 or proximal M2 occlusion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 3CompletedFinished
202420252026
First PostedJan 24, 2024
Enrollment StartJan 25, 2024
Primary CompletionOct 13, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 2.4 years ago

Interventions

Tenecteplasedrug

Tenecteplase (0.25 mg/kg, maximum dose 25mg) is given as a single, intravenous bolus (injection over 5 to 10 seconds) immediately upon randomization. EVT should be performed as soon as possible after Tenecteplase administration.

direct EVTdevice

During the study period, NMPA-approved stents are permitted. EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.