NCT05141305

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE), controlled phase 3 trial (2 arms with 1:1 randomization) in ischemic stroke due to anterior circulation large vessel occlusion with perfusion mismatch up to 24 hours of symptom onset. The target mismatch profiles on CTP or MRI perfusion weighted imaging include ischemic core volume \<70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL demonstrated by a certified automatic software. The minimum sample size is 516 patients.

Conditions

• Ischemic Stroke, Acute

Interventions

Type	Name	Description
DRUG	tenecteplase (0.25 mg/kg, Max 25 mg)	tenecteplase (0.25 mg/kg) is being used.
DRUG	standard medical treatment	Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone are being used.

Timeline

• Start date: 2022-01-19
• Primary completion: 2024-01-29
• Completion: 2024-02-09
• First posted: 2021-12-02
• Last updated: 2024-04-30

Locations

1 site across 1 country: China