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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121883
• Other study ID #: EDMETS
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD, MD
• Phone: 13958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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)

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Growth in infarct volume (mL)	24 hour infarct volume (mL) - 7 day infarct volume (mL)	from 24 hours to 7 days
Secondary	Salvaged ischemic tissue index (%)	100%*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL)	from baseline to 7 days
Secondary	Frequency of parenchymal hemorrhage (PH) (%)	The presence of PH is defined according the standard from ECASS-2 study thrombectomy	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Recovery assessed by modefied Rankin Scale (mRS) score	mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome	90 days