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Clinical study of Edaravone Dexborneol injection in the treatment of thrombolysis in patients with acute ischemic stroke

Clinical study of Edaravone Dexborneol injection in the treatment of thrombolysis in patients with acute ischemic stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059563
Enrollment
Unknown
Registered
2022-05-04
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke (AIS)

Interventions

Experimental group:Treatment of Edaravone Dexborneol injection
Control group:Standard treatment of AIS

Sponsors

Department of Neurology, Ruian People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as ischemic stroke; 2. Aged 18-80 years; 3. Receive intravenous thrombolytic therapy with RT-PA within 4.5 hours of stroke onset; 4. Informed consent signed by patients or their family members.

Exclusion criteria

Exclusion criteria: 1. Intracranial hemorrhagic diseases observed by head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; 2. Severe disturbance of consciousness: NIHSS scored more than 1 in item 1a of consciousness level; 3. Patients with severe mental disorders and dementia; 4. mRS score was >1 before the onset of the disease; 5. Transient ischemic attack (TIA); 6. After blood pressure control, systolic blood pressure was still >=220mmHg or diastolic blood pressure >=120mmHg; 7. Free radical scavenger such as Edaravone and reduced glutathione have been applied since the onset of the disease; 8. ALT or AST>2.0xULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, cirrhosis, previously known kidney disease, renal insufficiency, serum creatinine >1.5xULN or creatinine clearance <50mL/min; 9. Concurrent malignant tumor or undergoing antitumor therapy; 10. Severe systemic disease with an estimated survival of less than 90 days; 11. Allergic to Edaravone, (+) -2-camphenol, or excipients; 12. Patients during pregnancy, lactation and planning pregnancy; 13. Other conditions deemed unsuitable for participation in this clinical study by the investigator.

Design outcomes

Primary

MeasureTime frame
Modified Rankin scale score at 90 days;

Countries

China

Contacts

Public ContactHuang Xuerong
hxr02@126.com+86 13958860081

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026