Status:

COMPLETED

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

Lead Sponsor:

Hui-Sheng Chen

Conditions:

Stroke

Endovascular Thrombectomy

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 18 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

February 23 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 10 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04667637

Start Date

February 23 2021

End Date

October 10 2022

Last Update

October 12 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

General Hospital of Northern Theater Command

Shenyang, China, 110840