Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

NCT ID: NCT06645522

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2027-01-30

Brief Summary

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Detailed Description

In this study, 1200 patients with acute ischemic stroke within 48 hours from the onset are included in several centres in China according to the principles of randomization, double-blind, and parallel control. The experimental group receives basic treatment and edaravone dexborneol injection for 7 consecutive days, and sequentially receives a sublingual dose of edaravone dexborneol for 21 consecutive days. The placebo group receives basic treatment and edaravone dexborneol placebo injection for 7 consecutive days and sequentially receives a sublingual dose of edaravone dexborneol placebo drug for 21 consecutive days. Two groups will be followed up at day 90 to evaluate the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Study Design

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

Study Groups

Edaravone dexborneol group

Edaravone dexborneol injection 37.5mg every 12 hours for 7 days and a sublingual dose of edaravone dexborneol 36 mg twice a day for 21 days.

Group Type: EXPERIMENTAL

Edaravone dexborneol

Intervention Type: DRUG

Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.

Placebo group

Placebo injection every 12 hours for 7 days and a sublingual dose of placebo drug twice a day for 21 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.

Interventions

Edaravone dexborneol

Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.

Intervention Type: DRUG

Placebo

Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender;

2. Patients diagnosed as acute ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", and able to randomise and initiate edaravone dexborneol treatment less than or equal to 48 hours of stroke onset.

3. Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;

4. modified Rankin Scale (mRS) score of 1 or less before onset.

5. Did not receive edaravone dexborneol treatment before enrollment;

6. The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.

Exclusion Criteria

1. Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset.

2. Transient ischemic attack (TIA);

3. Posterior circulation stroke;

4. Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;

5. Severe disturbance of consciousness: the item score of 1a consciousness level of NIHSS was more than 1;

6. Patients with severe mental disorders and dementia;

7. Systolic blood pressure after blood pressure control is still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg;

8. Severe cardiac insufficiency, dissection and acute pericarditis; Severe liver insufficiency, ALT or AST > 3.0 × ULN; Or severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc;Severe renal insufficiency, Serum Creatinine (SCr) is greater than 200μmol/L, Creatinine Clearance (CrCl) is less than 30 ml/min or receiving hemodialysis; Or suffering from severe systemic diseases, the estimated survival time is less than 90 days;

9. Complicated with malignant tumor or undergoing anti-tumor treatment;

10. Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase, Ginkgolide.

11. Patients during pregnancy, lactation and planned pregnancy;

12. Allergic to dexborneol or edaravone or excipients;

13. Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;

14. Patients who are unwilling to be followed up，and 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

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Vice President of the First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Central Contacts

Yi Yang, MD,PhD

Role: CONTACT

doctoryangyi@163.com

13756661217 ext. 0086

Zhen-Ni Guo, MD,PhD

Role: CONTACT

zhen1ni2@163.com

18186872986 ext. 0086

Facility Contacts

Yi Yang, MD,PhD

Role: primary

doctoryangyi@163.com

+86-18186872986

Other Identifiers

ED-AIS

Identifier Type: -

Identifier Source: org_study_id