NCT05249920

Treatment of Acute Ischemic STroke With Edaravone Dexborneol II (TASTE-2)

Treatment of Acute Ischemic STroke With Edaravone Dexborneol Ⅱ (TASTE-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,362 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicentre, randomized, double-blind, placebo parallel controlled, investigator-sponsored study that aims to investigate the efficacy and safety of Edaravone Dexborneol treatment in patients with acute ischemic stroke who had received early reperfusion therapy.

Detailed description

This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy and safety of Edaravone Dexborneol treatment in patients with acute ischemic stroke who had received early reperfusion therapy. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio after the ICF was received. Patients in one arm will be given 15 ml edaravone and dexborneol concentrated solution for injection (37.5 mg, containing edaravone 30 mg and dexborneol 7.5 mg) twice a day for 10-14 days, and those in the other arm will be given an equivalent placebo drug. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2 and the safety outcome is the proportion of severe adverse events.

Conditions

• Acute Ischemic Stroke
• Mechanical Thrombectomy
• Edaravone Dexborneol
• Phase III

Interventions

Type	Name	Description
DRUG	Edaravone Dexborneol Concentrated Solution for injection	Edaravone and Dexborneol Concentrated Solution for Injection, 15 ml (37.5 mg, containing edaravone 30 mg and dexborneol 7.5 mg) in 3 ampoule bottles, twice a day for 10 to 14 days.
DRUG	Edaravone Dexborneol placebo	Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.

Timeline

• Start date: 2022-03-18
• Primary completion: 2023-02-17
• Completion: 2023-05-19
• First posted: 2022-02-22
• Last updated: 2023-08-22

Locations

1 site across 1 country: China