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

• Sponsor: Beijing Tiantan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05249920
• Collaborator: (none)
• Enrollment: 1,362
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.4
• Patients Per Site Per Month: 53.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke; Mechanical Thrombectomy; Edaravone Dexborneol; Phase III	Drug: Edaravone Dexborneol Concentrated Solution for injection; Drug: Edaravone Dexborneol placebo	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1362 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Acute Ischemic STroke With Edaravone Dexborneol Ⅱ (TASTE-2)
• Actual Study Start Date: Mar 18, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Edaravone Dexborneol group 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 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.; Other Names: Xian Bi Xin, CFDA Approval Number H20200007
Placebo Comparator: Edaravone Dexborneol Placebo group 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 placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.; Other Names: Xian Bi Xin placebo

Outcome Measures

Primary Outcome Measures

1. Favorable functional outcome [at 90 days after randomization]

   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

2. Incidence of severe adverse event (Safety outcome) [at 90 days after randomization]

   The incidence of Severe Adverse Event (SAE) emerged during the whole study period

Secondary Outcome Measures

1. Excellent functional outcome [at 90 days after randomization]

   Rate of excellent functional outcome defined as a mRS score 0-1

2. NIHSS score change [at 10-14 days after randomization]

   The change of NIHSS score defined as the NIHSS score of day 10-14 minus that of baseline

3. NIHSS score decreases ≥4 [at 10-14 days after randomization]

   Defined as the proportion of patients with NIHSS score decrease ≥ 4 from day 10-14 to baseline

4. All-cause mortality [at 90 days after randomization]

   All-cause mortality at 90 days after randomization

5. Symptomatic intracranial hemorrhage (sICH) [at 24-36 hours after randomization]

   The proportion of patients who experienced sICH

6. Neurological deterioration [at day 1 after randomization]

   Defined as the NIHSS score increases ≥4 from day 1 to baseline

7. Stroke recurrence [within 90 days after randomization]

   Defined as a new ischemic or hemorrhagic stroke occurred within 90 days after randomization

8. Adverse events (AE) [within 90 days after randomization]

   The proportion of patients who experienced AE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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);

1. Planned to receive bridging therapy (endovascular therapy after intravenous alteplase) or direct endovascular therapy;

2. Pre-morbid modified Rankin Scale ≤1;

3. 6 ≤ NIHSS ≤ 25 before endovascular therapy;

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100070

Sponsors and Collaborators

• Beijing Tiantan Hospital

Investigators

• Principal Investigator: Yongjun Wang, MD., Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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 Investigators†. 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.

• Responsible Party: Yongjun Wang, President of Beijing Tiantan Hospital, Capital Medical University, Beijing Tiantan Hospital
• ClinicalTrials.gov Identifier: NCT05249920
• Other Study ID Numbers: NCRC-2021-01
• First Posted: Feb 22, 2022
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Edaravone

Study Results

No Results Posted as of Mar 21, 2022