General Hospital of Northern Theater Command
Shenyang, 110840, China
NCT Number: NCT04667637
To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Shenyang, 110840, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.
Other names: edaravone deborbeol placebo
Time frame: Day 90
Proportion of patients with modified Rankin Score 0 to 2
Time frame: Day 90
Proportion of patients with modified Rankin Score 0 to 1
Time frame: Day 90
Distribution of modified Rankin Score after the treatment
Time frame: 24 hours, 48 hours, and 2 weeks
the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome
Time frame: 1 week
infarct volume is determinted by CT or DWI
Time frame: 48 hours
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Time frame: 48 hours
Proportion of PH1 and PH2 within 48 hours after the treatment
Time frame: Day 90
death due to any cause
Hui-Sheng Chen
Other
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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