Clinical trial NCT04667637: Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol
Official title: Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Endovascular Thrombectomy
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2020-12-16
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 the treatment of acute ischemic stroke patients who received endovascular thrombectomy.


Eligibility criteria: Inclusion Criteria:

1. 18 to 80 years of age;
2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
3. Sufficient recanalization within 9 hours of stroke onset;
4. Sufficient recanalization （TICI 2b-3）;
5. Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment;
6. First ever stroke or mRS≤1 after previous disease
7. The availability of informed consent.

Exclusion Criteria:

1. Acute ischemic stroke patients with insufficient recanalization（TICI \< 2a）
2. Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;
3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3）;
5. 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;
6. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
7. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
8. Pregnancy, plan to get pregnant or during lactation;
9. Patients with contraindication or allergic to any ingredient of drugs in our study;
10. Unsuitable for this clinical studies assessed by researcher.

Primary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: Day 90
Secondary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: Day 90
measure: Distribution of modified Rankin Score
timeFrame: Day 90
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 hours, 48 hours, and 2 weeks
measure: Change in infarct volume
timeFrame: 1 week
Other outcomes:
measure: Proportion of symptomatic intracranial hemorrhage (sICH)
timeFrame: 48 hours
measure: Proportion of intraparenchymal hemorrhage (PH1 and PH2)
timeFrame: 48 hours
measure: Proportion of death
timeFrame: Day 90
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References: