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

Stroke, Ischemic Clinical Trial

Official title:

Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05035953
• Other study ID #: SMA-AIS-003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 13, 2021
• Est. completion date: March 13, 2024

Study information

• Verified date: September 2021
• Source: Huashan Hospital
• Contact: Qiang Dong
• Phone: 86-21-52887142
• Email: qiang_dong163[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 13, 2024
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• Edaravone Dexborneol
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, addition to thrombolysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Shanghai Stroke Association

Outcome

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