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

NCT04667637 | Completed Phase 2

• 1 other identifier: Y(2020)045
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with modified Rankin Score 0 to 2

  Proportion of patients with modified Rankin Score 0 to 2

  Day 90

Secondary Outcomes (4)

• Proportion of patients with modified Rankin Score 0 to 1

  Day 90

• Distribution of modified Rankin Score

  Day 90

• Changes in National Institute of Health stroke scale (NIHSS)

  24 hours, 48 hours, and 2 weeks

• Change in infarct volume

  1 week

Other Outcomes (3)

• Proportion of symptomatic intracranial hemorrhage (sICH)

  48 hours

• Proportion of intraparenchymal hemorrhage (PH1 and PH2)

  48 hours

• Proportion of death

  Day 90

Study Arms (2)

0.9% NaCl

PLACEBO COMPARATOR

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

Drug: edaravone dexborneol

Edaravone Dexborneol

EXPERIMENTAL

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

Drug: edaravone dexborneol

Interventions

edaravone dexborneol DRUG

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

Also known as: edaravone deborbeol placebo

0.9% NaCl; Edaravone Dexborneol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hui-Sheng Chen: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location

Related Publications (1)

• Chen HS, Zhao ZA, Shen XY, Qiu SQ, Cui Y, Qiu J, Li W, Zhang H, Chen WH, Wang LH, Zhang DH, Chen Y, Ma YT, Gao ZE, Wang SC, Li D, Liu H, Nguyen TN. Edaravone dexborneol for ischemic stroke with sufficient recanalization after thrombectomy: a randomized phase II trial. Nat Commun. 2025 Mar 10;16(1):2393. doi: 10.1038/s41467-025-57774-x.

  PMID: 40064868 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: February 23, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)