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Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

Primary Purpose

Stroke, Endovascular Thrombectomy

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

edaravone dexborneol

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

18 to 80 years of age;
Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
Sufficient recanalization within 9 hours of stroke onset;
Sufficient recanalization （TICI 2b-3）;
Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment;
First ever stroke or mRS≤1 after previous disease
The availability of informed consent.

Exclusion Criteria:

Acute ischemic stroke patients with insufficient recanalization（TICI < 2a）
Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;
Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）;
Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
Pregnancy, plan to get pregnant or during lactation;
Patients with contraindication or allergic to any ingredient of drugs in our study;
Unsuitable for this clinical studies assessed by researcher.

Sites / Locations

General Hospital of Northern Theater Command

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

0.9% NaCl

Edaravone Dexborneol

Arm Description

Intravenous injections of 0.9% NaCl BID for 12 ±2days.

Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days.

Outcomes

Primary Outcome Measures

Proportion of patients with modified Rankin Score 0 to 2

Secondary Outcome Measures

Proportion of patients with modified Rankin Score 0 to 1

Distribution of modified Rankin Score

Distribution of modified Rankin Score after the treatment

Changes in National Institute of Health stroke scale (NIHSS)

the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome

Change in infarct volume

infarct volume is determinted by CT or DWI

Full Information

NCT ID

NCT04667637

First Posted

December 8, 2020

Last Updated

October 9, 2022

Sponsor

Hui-Sheng Chen

1. Study Identification

Unique Protocol Identification Number

NCT04667637

Brief Title

Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

Official Title

Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

February 23, 2021 (Actual)

Primary Completion Date

October 10, 2022 (Actual)

Study Completion Date

October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hui-Sheng Chen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.

6. Conditions and Keywords

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

Stroke, Endovascular Thrombectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.9% NaCl

Arm Type

Placebo Comparator

Arm Description

Intravenous injections of 0.9% NaCl BID for 12 ±2days.

Arm Title

Edaravone Dexborneol

Arm Type

Experimental

Arm Description

Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days.

Intervention Type

Drug

Intervention Name(s)

edaravone dexborneol

Other Intervention Name(s)

edaravone deborbeol placebo

Intervention Description

Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.

Primary Outcome Measure Information:

Title

Proportion of patients with modified Rankin Score 0 to 2

Description

Proportion of patients with modified Rankin Score 0 to 2

Time Frame

Day 90

Secondary Outcome Measure Information:

Title

Proportion of patients with modified Rankin Score 0 to 1

Description

Proportion of patients with modified Rankin Score 0 to 1

Time Frame

Day 90

Title

Distribution of modified Rankin Score

Description

Distribution of modified Rankin Score after the treatment

Time Frame

Day 90

Title

Changes in National Institute of Health stroke scale (NIHSS)

Description

the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome

Time Frame

24 hours, 48 hours, and 2 weeks

Title

Change in infarct volume

Description

infarct volume is determinted by CT or DWI

Time Frame

1 week

Other Pre-specified Outcome Measures:

Title

Proportion of symptomatic intracranial hemorrhage (sICH)

Description

sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

Time Frame

48 hours

Title

Proportion of intraparenchymal hemorrhage (PH1 and PH2)

Description

Proportion of PH1 and PH2 within 48 hours after the treatment

Time Frame

48 hours

Title

Proportion of death

Description

death due to any cause

Time Frame

Day 90

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 to 80 years of age; Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy; Sufficient recanalization within 9 hours of stroke onset; Sufficient recanalization （TICI 2b-3）; Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment; First ever stroke or mRS≤1 after previous disease The availability of informed consent. Exclusion Criteria: Acute ischemic stroke patients with insufficient recanalization（TICI < 2a） Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately; Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）; Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg); Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months; Pregnancy, plan to get pregnant or during lactation; Patients with contraindication or allergic to any ingredient of drugs in our study; Unsuitable for this clinical studies assessed by researcher.

Facility Information:

Facility Name

General Hospital of Northern Theater Command

City

ShenYang

ZIP/Postal Code

110840

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

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