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Completed

NCT Number: NCT04667637

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

General Hospital of Northern Theater Command

Shenyang, 110840, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Edaravone dexborneol

Drug

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

Other names: edaravone deborbeol placebo

Primary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 2

    Time frame: Day 90

    Proportion of patients with modified Rankin Score 0 to 2

Secondary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 1

    Time frame: Day 90

    Proportion of patients with modified Rankin Score 0 to 1

  2. Distribution of modified Rankin Score

    Time frame: Day 90

    Distribution of modified Rankin Score after the treatment

  3. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 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

  4. Change in infarct volume

    Time frame: 1 week

    infarct volume is determinted by CT or DWI

Other outcomes

  1. Proportion of symptomatic intracranial hemorrhage (sICH)

    Time frame: 48 hours

    sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

  2. Proportion of intraparenchymal hemorrhage (PH1 and PH2)

    Time frame: 48 hours

    Proportion of PH1 and PH2 within 48 hours after the treatment

  3. Proportion of death

    Time frame: Day 90

    death due to any cause

Sponsors and collaborators

Lead sponsor

Hui-Sheng Chen

Other

Registry information

Official study title

Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2020
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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