CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 516 enrolled
Drug / intervention
tenecteplase (0.25 mg/kg, Max 25 mg) +1 moredrug
Likely dose
tenecteplase (0.25 mg/kg, Max 25 mg)from 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/NCT05141305
NCT05141305Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion With Perfusion Mismatch up to 24 Hours of Symptom Onset

Beijing Tiantan Hospital·interventional·Posted Dec 2, 2021·Updated Apr 30, 2024

In Brief

A Phase 3 clinical trial evaluating tenecteplase (0.25 mg/kg, Max 25 mg) and standard medical treatment for Ischemic Stroke, Acute. Completed, enrolled 516 participants across 1 site.

Detailed Summary

The trial is a phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to anterior circulation large vessel occlusion within 4.5-24 hours from last known well (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke, Acute
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedDec 2, 2021
Enrollment StartJan 19, 2022
Primary CompletionJan 29, 2024
Study CompletionFeb 9, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.6 years ago

Interventions

tenecteplase (0.25 mg/kg, Max 25 mg)drug

tenecteplase (0.25 mg/kg) is being used.

standard medical treatmentdrug

Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone are being used.