Thrombolysis Combined With Edaravone Dexborneol on Hemorr... | NCT05035953

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

NCT05035953

Sponsor

Huashan Hospital

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

Stroke, Ischemic

Interventions

Edaravone Dexborneol
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2021Estimated

Primary Completion Date

Sep 13, 2023Estimated

Completion Date

Mar 13, 2024Estimated

First Submitted Date

Sep 3, 2021

First Submission Date that Met QC Criteria

Sep 3, 2021

First Posted Date

Sep 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2021

Last Update Posted Date

Sep 5, 2021Actual

Name	Class
Shanghai Stroke Association	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Edaravone	Experimental	Edaravone Dexborneol injection	Drug: Edaravone Dexborneol
Placebo	Placebo Comparator	Edaravone Dexborneol matching injection	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Edaravone Dexborneol	Drug	Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis	Edaravone

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

Measure	Description	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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases