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

Phase 2

Completed

• Conditions: Endovascular Thrombectomy; Stroke
• Interventions: Drug: edaravone dexborneol

• Registration Number: NCT04667637
• Lead Sponsor: Hui-Sheng Chen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-16
• Study Start: 2021-02-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-09
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% NaCl	edaravone dexborneol	Intravenous injections of 0.9% NaCl BID for 12 ±2days.
Edaravone Dexborneol	edaravone dexborneol	Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Score 0 to 2	Day 90	Proportion of patients with modified Rankin Score 0 to 2

Secondary Outcome Measures

Name	Time	Method
Distribution of modified Rankin Score	Day 90	Distribution of modified Rankin Score after the treatment
Change in infarct volume	1 week	infarct volume is determinted by CT or DWI
Proportion of patients with modified Rankin Score 0 to 1	Day 90	Proportion of patients with modified Rankin Score 0 to 1
Changes in National Institute of Health stroke scale (NIHSS)	24 hours, 48 hours, and 2 weeks	the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 ShenYang, China