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

NCT ID: NCT04667637

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2022-10-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.9% NaCl

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

Group Type: PLACEBO_COMPARATOR

edaravone dexborneol

Intervention Type: DRUG

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

Edaravone Dexborneol

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

Group Type: EXPERIMENTAL

edaravone dexborneol

Intervention Type: DRUG

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

Interventions

edaravone dexborneol

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

Intervention Type: DRUG

Other Intervention Names

edaravone deborbeol placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui-Sheng Chen

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40064868 (View on PubMed)

Other Identifiers

Y(2020)045

Identifier Type: -

Identifier Source: org_study_id