Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke

• Status: Not yet recruiting
• Trial end date: 2024-03-13
• Target enrollment: 0
• Participant gender: All

Summary

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Collaborator: Shanghai Stroke Association
• Treatments: Edaravone

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.