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Not yet taking people in ChinaPhase 4

Tests edaravone dexborneol for acute ischemic stroke

Tests edaravone dexborneol against placebo in adults with acute ischemic stroke.

Key facts

Who runs it
Yi Yang
Where
Changchun, ChinaSee the site
Trial code
Registry title
Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke
Status
Not yet recruiting
Phase
Phase 4
People taking part
1,200 people, planned
Started
30 Oct 2024
Expected to end
30 Jan 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Edaravone dexborneol
  • Placebo
Record updated
17 October 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 who had an acute ischemic stroke within the last 48 hours and have a moderate to fairly severe stroke. It tests edaravone dexborneol against a placebo.

Age
18 to 80 years old
Sex
Women and men can join.
Disease stage
Acute ischemic stroke, with treatment starting within 48 hours of stroke onset. NIHSS score total of 6 to 24, and the arm score plus the leg score together at least 2. mRS score of 1 or less before the stroke.
Earlier treatment
No edaravone dexborneol before enrolment. No clot-dissolving or clot-removal treatment (reperfusion therapy) after the stroke, received or planned. No neuroprotective drugs after the stroke, such as commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase or Ginkgolide.

Main reasons for not taking part

  • Transient ischemic attack (TIA), posterior circulation stroke, or bleeding in the brain
  • Severe disturbance of consciousness, severe mental disorder or dementia
  • Very high blood pressure despite treatment (systolic above 220mmhg or diastolic above 120mmhg)
  • Severe heart, liver or kidney problems (including hemodialysis), or other severe illness with expected survival under 90 days
  • Cancer or anti-cancer treatment, pregnancy, breastfeeding or planned pregnancy, or allergy to dexborneol or edaravone

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Age ≥ 18 years old and ≤ 80 years old, regardless of gender
  • Patients diagnosed as acute ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", and able to randomise and initiate edaravone dexborneol treatment less than or equal to 48 hours of stroke onset
  • Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2
  • modified Rankin Scale (mRS) score of 1 or less before onset
  • Did not receive edaravone dexborneol treatment before enrollment
  • The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative

Who cannot take part

  • Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset
  • Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization
  • Posterior circulation stroke
  • Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc
  • Patients with severe mental disorders and dementia
  • Complicated with malignant tumor or undergoing anti-tumor treatment
  • Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase, Ginkgolide
  • Allergic to dexborneol or edaravone or excipients
  • Severe cardiac insufficiency, dissection and acute pericarditis; Severe liver insufficiency, ALT or AST > 3.0 × ULN; Or severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc;Severe renal insufficiency, Serum Creatinine (SCr) is greater than 200μmol/L, Creatinine Clearance (CrCl) is less than 30 ml/min or receiving hemodialysis; Or suffering from severe systemic diseases, the estimated survival time is less than 90 days
  • Transient ischemic attack (TIA)
  • Severe disturbance of consciousness: the item score of 1a consciousness level of NIHSS was more than 1
  • Systolic blood pressure after blood pressure control is still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg
  • Patients during pregnancy, lactation and planned pregnancy
  • Patients who are unwilling to be followed up,and the investigators consider the patients are not suitable for this trial

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • The First Hospital of Jilin UniversityChangchun, ChinaContact: Yi Yang, MD,PhDNo longer taking part

About the trial

What the trial wants to find out

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

The 2 groups in the trial

  • Edaravone dexborneol groupTreatment being tested

    Edaravone dexborneol injection 37.5mg every 12 hours for 7 days and a sublingual dose of edaravone dexborneol 36 mg twice a day for 21 days.

    Treatment: Edaravone dexborneol

  • Placebo groupPlacebo, for comparison

    Placebo injection every 12 hours for 7 days and a sublingual dose of placebo drug twice a day for 21 days.

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Plain-language title
Tests edaravone dexborneol for acute ischemic strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06645522, who can take part
Record updated
17 October 2024