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

Beijing Tiantan Hospital1,362 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,362

Conditions

Acute Ischemic Stroke Mechanical Thrombectomy Edaravone Dexborneol Phase III

Interventions

Edaravone Dexborneol Concentrated Solution for injectionDRUG

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.

Edaravone Dexborneol placeboDRUG

Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 - 80 years, male or female; 2. Clinically diagnosed as acute anterior ischemic stroke, artery occlusion occurred at the terminal of the intracranial carotid artery, T-shaped bifurcation or M1 segment of the middle cerebral artery; 3. Within 24 hours of stroke onset; 4. 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); 5. Planned to receive bridging therapy (endovascular therapy after intravenous alteplase) or direct endovascular therapy; 6. Pre-morbid modified Rankin Scale ≤1; 7. 6 ≤ NIHSS ≤ 25 before endovascular therapy; 8. Signed informed consent from subjects or legally authorized representatives Exclusion Criteria: 1. CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subdural hematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.; 2. Had been given any intravenous thrombolytic drug other than alteplase before bridging therapy; 3. Hypersensitive to edaravone, (+)-2- dexborneol or auxiliary materials; 4. Prior receipt of edaravone or any other neuroprotective drugs; 5. History of congenital or acquired hemorrhagic disease, coagulation factor deficiency disease, or thrombocytopenic disease, etc.; 6. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg after antihypertensive treatment; 7. Serum alanine aminotransferase (ALT) or aspartate transaminase (AST) elevates over 3 times of upper limit of normal; 8. Recent or current serum creatinine is known to exceed 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 60 mL/min; 9. Pregnancy, lactation, or planned pregnancy within 90 days; 10. Those who cannot complete informed consent or follow-up treatment due to severe mental disorder or dementia; 11. Those with a malignant tumor, severe systemic diseases, or predict survival time \<90 days; 12. Participate in another interventional clinical study within 30 days before randomization or participate in another interventional clinical study.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.