Clinical trial NCT05035953: Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke
Official title: Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke, Ischemic
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Stroke Association
First posted: 2021-09-05
Enrollment: 200
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: To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of symptomatic intracranial hemorrhage
timeFrame: 36-48 hours
Secondary outcomes:
measure: The proportion of symptomatic intracranial hemorrhage
timeFrame: 7 days
measure: The proportion of intracranial hemorrhage
timeFrame: 36-48 hours, 7 days
measure: The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1
timeFrame: 90 days
measure: The change in the NIH stroke scale (NIHSS) from the baseline
timeFrame: 36-48 hours, 7, 14 and 90 days
measure: The proportion of Participants With Barthel Index (BI) score greater than or equal to 95
timeFrame: 14 and 90 days
measure: Vascular recanalization
timeFrame: 36-48 hours
measure: Blood Brain Barrier Permeability
timeFrame: 36-48 hours
measure: Proportion of Encephaledema
timeFrame: 36-48 hours
measure: Proportion of Death
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
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