A Phase 3 interventional study of Edaravone Dexborneol Concentrated Solution for injection and Edaravone Dexborneol placebo in Acute Ischemic Stroke, Mechanical Thrombectomy and Edaravone Dexborneol, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Beijing Tiantan Hospital · Phase 3, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 1,362 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible for other imaging indications for bridging therapy or direct mechanical thrombectomy:
ASPECTS ≥6 certified by the latest brain CT imaging; Patients within 6-16 hours after stroke onset should meet the mismatch criteria, which was defined as infarction core volume \<70 ml, mismatch ratio ≥1.8 and the ischemic volume > 15 ml (DEFUSE-3 Criteria); or NIHSS score ≥ 10 with infarction -core volume \< 31 cm3, or NIHSS score ≥ 20 with infarction core volume ≤ 51 cm3 (DAWN Criteria); Patients within 16-24 hours after stroke onset should meet the mismatch criteria, which was defined as NIHSS score ≥ 10 with infarction-core volume \< 31 cm3, or NIHSS score ≥ 20 with infarction-core volume ≤ 51 cm3 (DAWN Criteria);
Exclusion Criteria:
Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.
Drug: Edaravone Dexborneol Concentrated Solution for injection
Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days.
Drug: Edaravone Dexborneol placebo
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.
Also known as: Xian Bi Xin, CFDA Approval Number H20200007
Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.
Also known as: Xian Bi Xin placebo
Favorable functional outcome
Rate of favorable functional outcome defined as a modified Rankin Scale (mRS, scores range from 0 to 6, with 0 to 2 indicating favorable outcome and 3 to 6 indicating unfavorable outcome including 6 as death) score of 0-2
Time frame: at 90 days after randomization
Incidence of severe adverse event (Safety outcome)
The incidence of Severe Adverse Event (SAE) emerged during the whole study period
Time frame: at 90 days after randomization
Excellent functional outcome
Rate of excellent functional outcome defined as a mRS score 0-1
Time frame: at 90 days after randomization
NIHSS score change
The change of NIHSS score defined as the NIHSS score of day 10-14 minus that of baseline
Time frame: at 10-14 days after randomization
NIHSS score decreases ≥4
Defined as the proportion of patients with NIHSS score decrease ≥ 4 from day 10-14 to baseline
Time frame: at 10-14 days after randomization
All-cause mortality
All-cause mortality at 90 days after randomization
Time frame: at 90 days after randomization
Symptomatic intracranial hemorrhage (sICH)
The proportion of patients who experienced sICH
Time frame: at 24-36 hours after randomization
Neurological deterioration
Defined as the NIHSS score increases ≥4 from day 1 to baseline
Time frame: at day 1 after randomization
Stroke recurrence
Defined as a new ischemic or hemorrhagic stroke occurred within 90 days after randomization
Time frame: within 90 days after randomization
Adverse events (AE)
The proportion of patients who experienced AE
Time frame: within 90 days after randomization
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital