Clinical trial NCT06645522: Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke
Official title: Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Edaravone Dexborneol
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: In this study, 1200 patients with acute ischemic stroke within 48 hours from the onset are included in several centres in China according to the principles of randomization, double-blind, and parallel control. The experimental group receives basic treatment and edaravone dexborneol injection for 7 consecutive days, and sequentially receives a sublingual dose of edaravone dexborneol for 21 consecutive days. The placebo group receives basic treatment and edaravone dexborneol placebo injection for 7 consecutive days and sequentially receives a sublingual dose of edaravone dexborneol placebo drug for 21 consecutive days. Two groups will be followed up at day 90 to evaluate the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender;
2. 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.
3. 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;
4. modified Rankin Scale (mRS) score of 1 or less before onset.
5. Did not receive edaravone dexborneol treatment before enrollment;
6. The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.

Exclusion Criteria:

1. Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset.
2. Transient ischemic attack (TIA);
3. Posterior circulation stroke;
4. Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
5. Severe disturbance of consciousness: the item score of 1a consciousness level of NIHSS was more than 1;
6. Patients with severe mental disorders and dementia;
7. Systolic blood pressure after blood pressure control is still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg;
8. 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;
9. Complicated with malignant tumor or undergoing anti-tumor treatment;
10. Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase, Ginkgolide.
11. Patients during pregnancy, lactation and planned pregnancy;
12. Allergic to dexborneol or edaravone or excipients;
13. Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;
14. Patients who are unwilling to be followed up，and the investigators consider the patients are not suitable for this trial.

Primary outcomes:
measure: modified rankin scale (mRS) score ≤ 1
timeFrame: Day 90 after randomization
Secondary outcomes:
measure: Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels
timeFrame: Day 3 after randomization
measure: Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels
timeFrame: Day 7 after randomization
measure: NIHSS score on day 7
timeFrame: Day 7 after randomization
measure: mRS score ≤ 2
timeFrame: Day 90 after randomization
measure: Distribution of mRS score
timeFrame: Day 90 after randomization
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: