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

NCT ID: NCT05035953

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2024-03-13

Brief Summary

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

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Edaravone

Edaravone Dexborneol injection

Group Type: EXPERIMENTAL

Edaravone Dexborneol

Intervention Type: DRUG

Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis

Placebo

Edaravone Dexborneol matching injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Edaravone Dexborneol matching injection, addition to thrombolysis

Interventions

Edaravone Dexborneol

Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis

Intervention Type: DRUG

Placebo

Edaravone Dexborneol matching injection, addition to thrombolysis

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Stroke Association

UNKNOWN

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qiang Dong

MD, PhD, Director of Neurology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qiang Dong

Role: CONTACT

qiang_dong163@163.com

86-21-52887142

Other Identifiers

SMA-AIS-003

Identifier Type: -

Identifier Source: org_study_id