NCT05745259

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）

Thrombolysis Treated by TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Control and Non-inferior Phase Ⅲ Trial, 3T Stroke-Ⅲ

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,630 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1 to 0.25mg/kg or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.

Detailed description

The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours. The sample size is 1630.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Alteplase	Alteplase 0.9mg/kg are being used.
DRUG	Tenecteplase	Tenecteplase 0.25mg/kg are being used.

Timeline

• Start date: 2022-10-26
• Primary completion: 2023-11-04
• Completion: 2024-03-29
• First posted: 2023-02-27
• Last updated: 2023-02-27

Locations

63 sites across 1 country: China