Clinical trial NCT04817527: Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke, Ischemic
Keywords: Endovascular therapy
Extended Time Windows
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 3 on day 90
timeFrame: 90 days
measure: Proportion of symptomatic intracranial hemorrhage (sICH)
timeFrame: 48 hours
measure: mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis
timeFrame: 90 days
Secondary outcomes:
measure: Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14
timeFrame: 14 days
measure: Distribution of modified Rankin Score after the treatment
timeFrame: 90 days
measure: Change in infarct volume
timeFrame: 7 days
measure: The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
timeFrame: 90 days
measure: Activity of Daily Living Scale(ADL) score on day 14, 30, 90
timeFrame: 90 days
measure: Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
timeFrame: 90 days
measure: Serum inflammatory factors changes on day 1 and day 7
timeFrame: 7 days
measure: Proportion of PH1 and PH2 within 48 hours after the treatment
timeFrame: 48 hours
measure: Midline shift on the CT scan
timeFrame: 7 days
measure: Proportion of death due to any cause
timeFrame: 90 days
measure: Proportion of Serious adverse events(SAE)
timeFrame: 90 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
References: