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

NCT05035953 | Unknown Phase 2

• 1 other identifier: SMA-AIS-003
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The proportion of symptomatic intracranial hemorrhage

  36-48 hours

Secondary Outcomes (9)

• The proportion of symptomatic intracranial hemorrhage

  7 days

• The proportion of intracranial hemorrhage

  36-48 hours, 7 days

• The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1

  90 days

• The change in the NIH stroke scale (NIHSS) from the baseline

  36-48 hours, 7, 14 and 90 days

• The proportion of Participants With Barthel Index (BI) score greater than or equal to 95

  14 and 90 days

Study Arms (2)

Edaravone

EXPERIMENTAL

Edaravone Dexborneol injection

Drug: Edaravone Dexborneol

Placebo

PLACEBO COMPARATOR

Edaravone Dexborneol matching injection

Drug: Placebo

Interventions

Edaravone Dexborneol DRUG

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

Edaravone

Placebo DRUG

Edaravone Dexborneol matching injection, addition to thrombolysis

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke;
• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Stroke Association: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Qiang Dong

CONTACT

86-21-52887142; qiang_dong163@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Director of Neurology Department

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 5, 2021
• Study Start: September 13, 2021
• Primary Completion: September 13, 2023
• Study Completion: March 13, 2024
• Last Updated: September 5, 2021

Record last verified: 2021-09