The Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With AIS

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

880

Participants

Timeline

Start Date

December 28, 2023

Primary Completion Date

March 28, 2025

Study Completion Date

May 30, 2025

Conditions
Subjects With Acute Ischemic Stroke
Interventions
DRUG

Edaravone Dexborneol Sequential Therapy

Sequential treatment started with intravenous injection of edaravone dextrocamphorol 37.5 mg, twice a day for 5-10 days. Then, Edaravone Dexborneol Sublingual Tablets 36.0 mg was taken sublingual twice a day for 14 days (the total course of the two drugs was 14 days, a total of 28 times).

DRUG

Placebo

Injection Simulants(Edaravone Dexborneol concentrated solution for injections) administered intravenously for 5 - 10 days, and then followed by Sublingual Tablet Simulants(Edaravone Dexborneol Sublingual Tablets) BID administered sublingually for the last days, the total duration of treatment was 14 days

All Listed Sponsors
lead

Simcere Pharmaceutical Co., Ltd

OTHER