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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Drug: Edaravone Dexborneol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiang Dong; Phone Number: 86-21-52887142; Email: qiang_dong163@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of symptomatic intracranial hemorrhage	36-48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Vascular recanalization	36-48 hours
Blood Brain Barrier Permeability	36-48 hours
Proportion of Encephaledema	36-48 hours
Proportion of Death	90 days

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Shanghai Stroke Association

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 13, 2021
• Primary Completion (ANTICIPATED): September 13, 2023
• Study Completion (ANTICIPATED): March 13, 2024

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (ACTUAL): September 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: SMA-AIS-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No