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

Capital Medical University

Status and phase: Completed; Phase 3

Conditions: Edaravone Dexborneol; Mechanical Thrombectomy; Acute Ischemic Stroke; Phase III

Treatments: Drug: Edaravone Dexborneol Concentrated Solution for injection; Drug: Edaravone Dexborneol placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05249920

NCRC-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,362 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,362 participants in 2 patient groups, including a placebo group

Edaravone Dexborneol group

Experimental group

Description:

Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.

Treatment:

Drug: Edaravone Dexborneol Concentrated Solution for injection

Edaravone Dexborneol Placebo group

Placebo Comparator group

Description:

Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days.

Treatment:

Drug: Edaravone Dexborneol placebo