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

NCT05249920 | Completed Phase 3

• 1 other identifier: NCRC-2021-01
• Study Type: interventional
• Target: 1,362
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  at 90 days after randomization

Secondary Outcomes (8)

• Excellent functional outcome

  at 90 days after randomization

• NIHSS score change

  at 10-14 days after randomization

• NIHSS score decreases ≥4

  at 10-14 days after randomization

• All-cause mortality

  at 90 days after randomization

• Symptomatic intracranial hemorrhage (sICH)

  at 24-36 hours after randomization

Study Arms (2)

Edaravone Dexborneol group

EXPERIMENTAL

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

Edaravone Dexborneol Placebo group

PLACEBO COMPARATOR

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

Interventions

Edaravone Dexborneol Concentrated Solution for injection DRUG

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 Dexborneol group

Edaravone Dexborneol placebo DRUG

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

Edaravone Dexborneol Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years, male or female;
• 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;
• Within 24 hours of stroke onset;
• 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);
• Planned to receive bridging therapy (endovascular therapy after intravenous alteplase) or direct endovascular therapy;
• Pre-morbid modified Rankin Scale ≤1;
• ≤ NIHSS ≤ 25 before endovascular therapy;
• Signed informed consent from subjects or legally authorized representatives

You may not qualify if:

• CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subdural hematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.;
• Had been given any intravenous thrombolytic drug other than alteplase before bridging therapy;
• Hypersensitive to edaravone, (+)-2- dexborneol or auxiliary materials;
• Prior receipt of edaravone or any other neuroprotective drugs;
• History of congenital or acquired hemorrhagic disease, coagulation factor deficiency disease, or thrombocytopenic disease, etc.;
• Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg after antihypertensive treatment;
• Serum alanine aminotransferase (ALT) or aspartate transaminase (AST) elevates over 3 times of upper limit of normal;
• 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;
• Pregnancy, lactation, or planned pregnancy within 90 days;
• Those who cannot complete informed consent or follow-up treatment due to severe mental disorder or dementia;
• Those with a malignant tumor, severe systemic diseases, or predict survival time \<90 days;
• Participate in another interventional clinical study within 30 days before randomization or participate in another interventional clinical study.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (3)

• Hill MD, Goyal M, Menon BK, Nogueira RG, McTaggart RA, Demchuk AM, Poppe AY, Buck BH, Field TS, Dowlatshahi D, van Adel BA, Swartz RH, Shah RA, Sauvageau E, Zerna C, Ospel JM, Joshi M, Almekhlafi MA, Ryckborst KJ, Lowerison MW, Heard K, Garman D, Haussen D, Cutting SM, Coutts SB, Roy D, Rempel JL, Rohr AC, Iancu D, Sahlas DJ, Yu AYX, Devlin TG, Hanel RA, Puetz V, Silver FL, Campbell BCV, Chapot R, Teitelbaum J, Mandzia JL, Kleinig TJ, Turkel-Parrella D, Heck D, Kelly ME, Bharatha A, Bang OY, Jadhav A, Gupta R, Frei DF, Tarpley JW, McDougall CG, Holmin S, Rha JH, Puri AS, Camden MC, Thomalla G, Choe H, Phillips SJ, Schindler JL, Thornton J, Nagel S, Heo JH, Sohn SI, Psychogios MN, Budzik RF, Starkman S, Martin CO, Burns PA, Murphy S, Lopez GA, English J, Tymianski M; ESCAPE-NA1 Investigators. Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial. Lancet. 2020 Mar 14;395(10227):878-887. doi: 10.1016/S0140-6736(20)30258-0. Epub 2020 Feb 20.

  PMID: 32087818 BACKGROUND

• Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.

  PMID: 33588596 BACKGROUND

• Wang C, Gu H, Huo X, Yuan B, Li S, Xu J, Jiang Y, Jing J, Yao X, Li Z, Long F, Ma Z, Zhuang X, Xu L, Jin Y, Huang W, Zhang Y, Wen J, Wang A, Pan Y, Ye W, Yu W, Cheng A, Wang M, Dong Q, Xu A, Wang N, Yang Y, Meng X, Liu L, Zhao X, Li H, Miao Z, Li Z, Wang Y; TASTE-2 investigators. Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial. BMJ. 2026 Jan 7;392:e086850. doi: 10.1136/bmj-2025-086850.

  PMID: 41500725 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yongjun Wang, MD.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Tiantan Hospital, Capital Medical University

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 22, 2022
• Study Start: March 18, 2022
• Primary Completion: February 17, 2023
• Study Completion: May 19, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)