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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Stroke, Ischemic

Treatments: Drug: Edaravone Dexborneol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05035953

SMA-AIS-003

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups, including a placebo group

Edaravone

Experimental group

Description:

Edaravone Dexborneol injection

Treatment:

Drug: Edaravone Dexborneol

Placebo

Placebo Comparator group

Description:

Edaravone Dexborneol matching injection

Treatment:

Drug: Placebo