Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke

Last updated: August 22, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Stroke

Cerebral Ischemia

Treatment

Edaravone Dexborneol

Clinical Study ID

NCT05121883
EDMETS
  • Ages 18-80
  • All Genders

Study Summary

Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients presenting with anterior circulation acute ischemic stroke
  • Patients aged between 18-80 years.
  • CTA or DSA verified arterial occlusion of ICA, M1 or M2.
  • NIHSS on admission 4 - 26
  • Baseline CTP verified infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8
  • Undergoing mechanical thrombectomy within 24 hours of stroke onset. For wake-upstroke, the onset time is determined as the midpoint of last-seen-well and discoveredtime

Exclusion

Exclusion Criteria:

  • Patients without recanalization (TICI 0,1, 2a)
  • Pre-existing neurological disability (a score greater than 2 on the mRS)
  • Contraindication of edaravone dexborneol

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Edaravone Dexborneol
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
January 31, 2024

Study Description

This is a prospective, non-randomized clinical trial in multiple stroke centres of China. The total sample size will be 200. Patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (MT) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. Only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. Patients in standard medication treatment group must not receive edaravone dexborneol. Other neuroprotective agents are not limited to use.

Connect with a study center

  • The second affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.