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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249920
• Other study ID #: NCRC-2021-01
• Status: Completed
• Phase: Phase 3
• Start date: March 18, 2022
• Est. completion date: May 19, 2023

Study information

• Verified date: August 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1362
• Est. completion date: May 19, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Mechanical Thrombectomy
• Phase III
• Stroke

Intervention

Drug:
• Edaravone Dexborneol Concentrated Solution for injection
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 placebo
Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Excellent functional outcome	Rate of excellent functional outcome defined as a mRS score 0-1	at 90 days after randomization
Secondary	NIHSS score change	The change of NIHSS score defined as the NIHSS score of day 10-14 minus that of baseline	at 10-14 days after randomization
Secondary	NIHSS score decreases =4	Defined as the proportion of patients with NIHSS score decrease = 4 from day 10-14 to baseline	at 10-14 days after randomization
Secondary	All-cause mortality	All-cause mortality at 90 days after randomization	at 90 days after randomization
Secondary	Symptomatic intracranial hemorrhage (sICH)	The proportion of patients who experienced sICH	at 24-36 hours after randomization
Secondary	Neurological deterioration	Defined as the NIHSS score increases =4 from day 1 to baseline	at day 1 after randomization
Secondary	Stroke recurrence	Defined as a new ischemic or hemorrhagic stroke occurred within 90 days after randomization	within 90 days after randomization
Secondary	Adverse events (AE)	The proportion of patients who experienced AE	within 90 days after randomization