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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05121883
Collaborator
(none)
200
Enrollment
1
Location
25
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Edaravone Dexborneol

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Trial of Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Edaravone dexborneol group

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 will be classified into this group.

Drug: Edaravone Dexborneol
Edaravone dexborneol (Jiangsu Simcere Pharmaceutical, Co, Ltd) will be initiated within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days (maximum: 14 days)

Standard medication group

Patients who do not recieve edaravone dexborneol will be classified into this group.

Outcome Measures

Primary Outcome Measures

  1. Proportion of functional independence at 90 days [90 days]

    Functional independence will be assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

Secondary Outcome Measures

  1. Growth in infarct volume (mL) [from 24 hours to 7 days]

    24 hour infarct volume (mL) - 7 day infarct volume (mL)

  2. Salvaged ischemic tissue index (%) [from baseline to 7 days]

    100%*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL)

  3. Frequency of parenchymal hemorrhage (PH) (%) [24 hours]

    The presence of PH is defined according the standard from ECASS-2 study thrombectomy

  4. Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day [from baseline to 1 day]

    NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms

  5. Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day [from 1 day to 7 days]

    NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms

  6. Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1 [90 days]

    mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

  7. Recovery assessed by modefied Rankin Scale (mRS) score [90 days]

    mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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-up stroke, the onset time is determined as the midpoint of last-seen-well and discovered time

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The second affiliated hospital of Zhejiang UniversityHangzhouZhejiangChina310009

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Min Lou, PhD, MD, the 2nd affiliated hospital of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05121883
Other Study ID Numbers:
  • EDMETS
First Posted:
Nov 16, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021