NCT04676659

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)

Phase II Dose-finding Open Study of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) Injection Administered Within 3 Hours After Onset of Hyperacute Ischemic Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the safe and efficacious dose of rhTNK-tPA injection administered within 3 hours after onset of hyperacute ischemic stroke; to provide dose evidence for phase III clinical trial.

Detailed description

To evaluate the safety and efficacy of rhTNK-tPA at different doses of 0.10 mg/kg, 0.25 mg/kg and 0.32 mg/kg compared with standard rt-PA intravenous thrombolytic therapy within 3 hours after onset of ischemic stroke. The primary objective of this study is to evaluate the differences of NIHSS scores among the four treatment groups at 14 days after intravenous thrombolysis.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	TNK-tPA	Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol

Timeline

• Start date: 2018-05-12
• Primary completion: 2020-05-30
• Completion: 2020-07-10
• First posted: 2020-12-21
• Last updated: 2020-12-21

Locations

24 sites across 1 country: China