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

• Sponsor: Huashan Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05035953
• Collaborator: Shanghai Stroke Association (Other)
• Enrollment: 200
• Arms: 2
• Anticipated Duration (Months): 30

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic	Drug: Edaravone Dexborneol; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
• Anticipated Study Start Date: Sep 13, 2021
• Anticipated Primary Completion Date: Sep 13, 2023
• Anticipated Study Completion Date: Mar 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Edaravone Edaravone Dexborneol injection	Drug: Edaravone Dexborneol; Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis
Placebo Comparator: Placebo Edaravone Dexborneol matching injection	Drug: Placebo; Edaravone Dexborneol matching injection, addition to thrombolysis

Outcome Measures

Primary Outcome Measures

1. The proportion of symptomatic intracranial hemorrhage [36-48 hours]

Secondary Outcome Measures

1. The proportion of symptomatic intracranial hemorrhage [7 days]

2. The proportion of intracranial hemorrhage [36-48 hours, 7 days]

3. The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1 [90 days]

4. The change in the NIH stroke scale (NIHSS) from the baseline [36-48 hours, 7, 14 and 90 days]

5. The proportion of Participants With Barthel Index (BI) score greater than or equal to 95 [14 and 90 days]

6. Vascular recanalization [36-48 hours]

7. Blood Brain Barrier Permeability [36-48 hours]

8. Proportion of Encephaledema [36-48 hours]

9. Proportion of Death [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Huashan Hospital
• Shanghai Stroke Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qiang Dong, MD, PhD, Director of Neurology Department, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT05035953
• Other Study ID Numbers: SMA-AIS-003
• First Posted: Sep 5, 2021
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Ischemia; Edaravone

Study Results

No Results Posted as of Sep 5, 2021