Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows

Stroke, Ischemic Clinical Trial

— EXISTENT  

Official title:

Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT):a Prospective, Randomized, Open-label, Multi-centre Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04817527
• Other study ID #: XJTU1AF2021LSK-065
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jianfeng Han, MD
• Phone: +8618991232708
• Email: rabbit1110[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18 to 80 years of age;

2. Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) = 10 and Volume of infarction on DWI <31ml or with a NIHSS =20 and 31ml<Volume of infarction<51ml(DWI);

3. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;

4. Endovascular Therapy in 6-24 hours of stroke onset;

5. The availability of informed consent.

Exclusion Criteria:

1. First ever stroke or mRS=1 after previous disease;

2. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;

3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia

4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;

5. Severe cardiac or pulmonary disease;

6. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;

7. Pregnancy, plan to get pregnant or during lactation;

8. Patients with contraindication or allergic to any ingredient of drugs in our study;

9. Unsuitable for this clinical studies assessed by researcher

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• Edaravone Dexborneol
Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with modified Rankin Score 0 to 3 on day 90		90 days
Primary	Proportion of symptomatic intracranial hemorrhage (sICH)		48 hours
Primary	mTICI grade (<2 b?=2 b) stratified for primary outcome analysis		90 days
Secondary	Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14		14 days
Secondary	Distribution of modified Rankin Score after the treatment		90 days
Secondary	Change in infarct volume		7 days
Secondary	The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90		90 days
Secondary	Activity of Daily Living Scale(ADL) score on day 14, 30, 90		90 days
Secondary	Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90		90 days
Secondary	Serum inflammatory factors changes on day 1 and day 7		7 days
Secondary	Proportion of PH1 and PH2 within 48 hours after the treatment		48 hours
Secondary	Midline shift on the CT scan		7 days
Secondary	Proportion of death due to any cause		90 days
Secondary	Proportion of Serious adverse events(SAE)		90 days