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

Primary Purpose

Acute Ischemic Stroke, Mechanical Thrombectomy, Edaravone Dexborneol

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Edaravone Dexborneol Concentrated Solution for injection

Edaravone Dexborneol placebo

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 - 80 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;
6 ≤ NIHSS ≤ 25 before endovascular therapy;
Signed informed consent from subjects or legally authorized representatives

Exclusion Criteria:

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.

Sites / Locations

Beijing Tiantan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Edaravone Dexborneol group

Edaravone Dexborneol Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Incidence of severe adverse event (Safety outcome)

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

Secondary Outcome Measures

Excellent functional outcome

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

NIHSS score change

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

NIHSS score decreases ≥4

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

All-cause mortality

All-cause mortality at 90 days after randomization

Symptomatic intracranial hemorrhage (sICH)

The proportion of patients who experienced sICH

Neurological deterioration

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

Stroke recurrence

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

Adverse events (AE)

The proportion of patients who experienced AE

Full Information

NCT ID

NCT05249920

First Posted

January 25, 2022

Last Updated

August 20, 2023

Sponsor

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05249920

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

March 18, 2022 (Actual)

Primary Completion Date

February 17, 2023 (Actual)

Study Completion Date

May 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1362 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Edaravone Dexborneol group

Arm Type

Experimental

Arm Description

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

Arm Title

Edaravone Dexborneol Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Edaravone Dexborneol Concentrated Solution for injection

Other Intervention Name(s)

Xian Bi Xin, CFDA Approval Number H20200007

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Edaravone Dexborneol placebo

Other Intervention Name(s)

Xian Bi Xin placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Favorable functional outcome

Description

Time Frame

at 90 days after randomization

Title

Incidence of severe adverse event (Safety outcome)

Description

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

Time Frame

at 90 days after randomization

Secondary Outcome Measure Information:

Title

Excellent functional outcome

Description

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

Time Frame

at 90 days after randomization

Title

NIHSS score change

Description

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

Title

NIHSS score decreases ≥4

Description

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

Title

All-cause mortality

Description

All-cause mortality at 90 days after randomization

Time Frame

at 90 days after randomization

Title

Symptomatic intracranial hemorrhage (sICH)

Description

The proportion of patients who experienced sICH

Time Frame

at 24-36 hours after randomization

Title

Neurological deterioration

Description

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

Time Frame

at day 1 after randomization

Title

Stroke recurrence

Description

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

Time Frame

within 90 days after randomization

Title

Adverse events (AE)

Description

The proportion of patients who experienced AE

Time Frame

within 90 days after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 - 80 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; 6 ≤ NIHSS ≤ 25 before endovascular therapy; Signed informed consent from subjects or legally authorized representatives Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongjun Wang, MD.

Organizational Affiliation

Beijing Tiantan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tiantan Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100070

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32087818

Citation

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.

Results Reference

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PubMed Identifier

33588596

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.

Results Reference

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

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