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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Endovascular Thrombectomy
• Intervention / Treatment: Drug: edaravone dexborneol

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • ShenYang, China, 110840
    • General Hospital of Northern Theater Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Acute ischemic stroke patients with insufficient recanalization（TICI < 2a）
2. Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;
3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）;
5. 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;
6. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
7. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
8. Pregnancy, plan to get pregnant or during lactation;
9. Patients with contraindication or allergic to any ingredient of drugs in our study;
10. Unsuitable for this clinical studies assessed by researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0.9% NaCl; Intravenous injections of 0.9% NaCl BID for 12 ±2days.	Drug: edaravone dexborneol; Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.; Other Names: edaravone deborbeol placebo
Experimental: Edaravone Dexborneol; Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days.	Drug: edaravone dexborneol; Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.; Other Names: edaravone deborbeol placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with modified Rankin Score 0 to 2	Proportion of patients with modified Rankin Score 0 to 2	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with modified Rankin Score 0 to 1	Proportion of patients with modified Rankin Score 0 to 1	Day 90
Distribution of modified Rankin Score	Distribution of modified Rankin Score after the treatment	Day 90
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	24 hours, 48 hours, and 2 weeks
Change in infarct volume	infarct volume is determinted by CT or DWI	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2)	Proportion of PH1 and PH2 within 48 hours after the treatment	48 hours
Proportion of death	death due to any cause	Day 90

Collaborators and Investigators

• Sponsor: Hui-Sheng Chen

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: Y(2020)045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No