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

Phase 2

• Conditions: Stroke, Ischemic
• Interventions: Drug: Edaravone Dexborneol; Drug: Placebo

• Registration Number: NCT05035953
• Lead Sponsor: Huashan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Last Update Submitted: 2021-09-03
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Study Start: 2021-09-13
• Primary Completion: 2023-09-13
• Study Completion: 2024-03-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edaravone	Edaravone Dexborneol	Edaravone Dexborneol injection
Placebo	Placebo	Edaravone Dexborneol matching injection

Primary Outcome Measures

Name	Time	Method
The proportion of symptomatic intracranial hemorrhage	36-48 hours

Secondary Outcome Measures

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