Clinical trial NCT05121883: Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
Official title: An Observational Trial of Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of functional independence at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Growth in infarct volume (mL)
timeFrame: from 24 hours to 7 days
measure: Salvaged ischemic tissue index (%)
timeFrame: from baseline to 7 days
measure: Frequency of parenchymal hemorrhage (PH) (%)
timeFrame: 24 hours
measure: Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day
timeFrame: from baseline to 1 day
measure: Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day
timeFrame: from 1 day to 7 days
measure: Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1
timeFrame: 90 days
measure: Recovery assessed by modefied Rankin Scale (mRS) score
timeFrame: 90 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: the 2nd affiliated hospital of Zhejiang University
name: Min Lou, PhD, MD
role: STUDY_CHAIR
References: