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

NCT05121883 | Unknown DMC

• 1 other identifier: EDMETS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Growth in infarct volume (mL)

  from 24 hours to 7 days

• Salvaged ischemic tissue index (%)

  from baseline to 7 days

• Frequency of parenchymal hemorrhage (PH) (%)

  24 hours

• Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day

  from baseline to 1 day

• Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day

  from 1 day to 7 days

Study Arms (2)

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

Standard medication group

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

Interventions

Edaravone Dexborneol DRUG

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)

Edaravone dexborneol group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Lou, PhD, MD

  the 2nd affiliated hospital of Zhejiang University

  STUDY CHAIR

Central Study Contacts

Min Lou, PhD, MD

CONTACT

13958007213; loumingxc@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 16, 2021
• Study Start: November 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: January 31, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-04

Locations

CN (1)