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

Hui-Sheng Chen

Status and phase: Completed; Phase 2

Conditions: Stroke; Endovascular Thrombectomy

Treatments: Drug: edaravone dexborneol

Study type: Interventional

Funder types: Other

Identifiers

NCT04667637

Y(2020)045

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

0.9% NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: edaravone dexborneol

Edaravone Dexborneol

Experimental group

Description:

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

Treatment:

Drug: edaravone dexborneol