Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667637
• Other study ID #: Y(2020)045
• Status: Completed
• Phase: Phase 2
• Start date: February 23, 2021
• Est. completion date: October 10, 2022

Study information

• Verified date: October 2022
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 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. 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.

Related Conditions & MeSH terms

• Endovascular Thrombectomy
• Ischemic Stroke
• Stroke

Intervention

Drug:
• edaravone dexborneol
Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
Hui-Sheng Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Other	Proportion of intraparenchymal hemorrhage (PH1 and PH2)	Proportion of PH1 and PH2 within 48 hours after the treatment	48 hours
Other	Proportion of death	death due to any cause	Day 90
Primary	Proportion of patients with modified Rankin Score 0 to 2	Proportion of patients with modified Rankin Score 0 to 2	Day 90
Secondary	Proportion of patients with modified Rankin Score 0 to 1	Proportion of patients with modified Rankin Score 0 to 1	Day 90
Secondary	Distribution of modified Rankin Score	Distribution of modified Rankin Score after the treatment	Day 90
Secondary	Changes in National Institute of Health stroke scale (NIHSS)	the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome	24 hours, 48 hours, and 2 weeks
Secondary	Change in infarct volume	infarct volume is determinted by CT or DWI	1 week