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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Min Lou, PhD, MD; Phone Number: 13958007213; Email: loumingxc@vip.sina.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University
      • Contact: Min Lou, PhD, MD; Phone Number: 13958007213; Email: loumingxc@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged between 18-80 years with anterior circulation stroke obtaining successful recanalization after mechanical thrombectomy within 24 hours of onset will be included. CTP prior to mechanical thrombectomy must be performed to verify infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8. Patients without recanalization after mechanical thrombectomy or have a pre-mRS greater than 2 will be excluded.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of functional independence at 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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth in infarct volume (mL)	24 hour infarct volume (mL) - 7 day infarct volume (mL)	from 24 hours to 7 days
Salvaged ischemic tissue index (%)	100%*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL)	from baseline to 7 days
Frequency of parenchymal hemorrhage (PH) (%)	The presence of PH is defined according the standard from ECASS-2 study thrombectomy	24 hours
Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day	NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms	from baseline to 1 day
Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day	NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms	from 1 day to 7 days
Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1	mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome	90 days
Recovery assessed by modefied Rankin Scale (mRS) score	mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome	90 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Min Lou, PhD, MD, The 2nd Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: EDMETS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED