NCT05281549

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

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Controlled Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial is prospective, block 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 1:1:1 to 0.25mg/kg or 0.40mg/kg intravenous tenecteplase 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 2 trial (3 arm with 1:1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-30 hours. The sample size is 225.

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.
DRUG	Tenecteplase	Tenecteplase 0.4mg/kg are being used.

Timeline

• Start date: 2021-05-02
• Primary completion: 2022-01-28
• Completion: 2022-05-31
• First posted: 2022-03-16
• Last updated: 2022-03-31

Locations

28 sites across 1 country: China