Stroke, Ischemic
Conditions
Brief summary
To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis.
Interventions
Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis
DRUGPlacebo
Edaravone Dexborneol matching injection, addition to thrombolysis
Sponsors
Shanghai Stroke Association
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Acute ischemic stroke; * 18 to 80 years of age; * There are clear signs of neurological deficit: 8≤NIHSS score≤24; * Received alteplase thrombolysis therapy within 4.5 hours after onset; * Patients signed written inform consent
Exclusion criteria
* Patients need endovascular therapy or bridge therapy; * Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage; * Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months; * Intracranial or intraspinal surgery within 3 months; * Active visceral hemorrhage * Major surgery within 2 weeks or arterial puncture within 1 week that is difficult to compress the hemostatic site; * Unknown onset time; * Rapid improvement of symptoms or mild symptoms before thrombolysis therapy; * A platelet count below 100,000/mm3 indicates a propensity for acute bleeding; * Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase; * Patients with severe mental disorders and dementia; * ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis; * Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases; * Patients with malignant tumors or severe systemic disease; * allergic to edaravone , (+)-Borneol or related excipients; * Pregnant or lactating women; * Have major surgery within 4 weeks before enrollment; * Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present; * The investigators consider the patients are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of symptomatic intracranial hemorrhage | 36-48 hours |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of symptomatic intracranial hemorrhage | 7 days |
| The proportion of intracranial hemorrhage | 36-48 hours, 7 days |
| The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1 | 90 days |
| The change in the NIH stroke scale (NIHSS) from the baseline | 36-48 hours, 7, 14 and 90 days |
| The proportion of Participants With Barthel Index (BI) score greater than or equal to 95 | 14 and 90 days |
| Vascular recanalization | 36-48 hours |
| Blood Brain Barrier Permeability | 36-48 hours |
| Proportion of Encephaledema | 36-48 hours |
| Proportion of Death | 90 days |
Contacts
Primary ContactQiang Dong
Outcome results
None listed