Status:
COMPLETED
Treatment of Acute Ischemic STroke With Edaravone Dexborneol II (TASTE-2)
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Acute Ischemic Stroke
Mechanical Thrombectomy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is a multicentre, randomized, double-blind, placebo parallel controlled, investigator-sponsored study that aims to investigate the efficacy and safety of Edaravone Dexborneol treatment in p...
Detailed Description
This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy and safety of Edaravone Dexborneol treatment in patients with acute ischemic stroke who ...
Eligibility Criteria
Inclusion
- 18 - 80 years, male or female;
- Clinically diagnosed as acute anterior ischemic stroke, artery occlusion occurred at the terminal of the intracranial carotid artery, T-shaped bifurcation or M1 segment of the middle cerebral artery;
- Within 24 hours of stroke onset;
- Eligible for other imaging indications for bridging therapy or direct mechanical thrombectomy:
- ASPECTS ≥6 certified by the latest brain CT imaging; Patients within 6-16 hours after stroke onset should meet the mismatch criteria, which was defined as infarction core volume \<70 ml, mismatch ratio ≥1.8 and the ischemic volume \> 15 ml (DEFUSE-3 Criteria); or NIHSS score ≥ 10 with infarction -core volume \< 31 cm3, or NIHSS score ≥ 20 with infarction core volume ≤ 51 cm3 (DAWN Criteria); Patients within 16-24 hours after stroke onset should meet the mismatch criteria, which was defined as NIHSS score ≥ 10 with infarction-core volume \< 31 cm3, or NIHSS score ≥ 20 with infarction-core volume ≤ 51 cm3 (DAWN Criteria);
- Planned to receive bridging therapy (endovascular therapy after intravenous alteplase) or direct endovascular therapy;
- Pre-morbid modified Rankin Scale ≤1;
- 6 ≤ NIHSS ≤ 25 before endovascular therapy;
- Signed informed consent from subjects or legally authorized representatives
Exclusion
- CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subdural hematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.;
- Had been given any intravenous thrombolytic drug other than alteplase before bridging therapy;
- Hypersensitive to edaravone, (+)-2- dexborneol or auxiliary materials;
- Prior receipt of edaravone or any other neuroprotective drugs;
- History of congenital or acquired hemorrhagic disease, coagulation factor deficiency disease, or thrombocytopenic disease, etc.;
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg after antihypertensive treatment;
- Serum alanine aminotransferase (ALT) or aspartate transaminase (AST) elevates over 3 times of upper limit of normal;
- Recent or current serum creatinine is known to exceed 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 60 mL/min;
- Pregnancy, lactation, or planned pregnancy within 90 days;
- Those who cannot complete informed consent or follow-up treatment due to severe mental disorder or dementia;
- Those with a malignant tumor, severe systemic diseases, or predict survival time \<90 days;
- Participate in another interventional clinical study within 30 days before randomization or participate in another interventional clinical study.
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2023
Estimated Enrollment :
1362 Patients enrolled
Trial Details
Trial ID
NCT05249920
Start Date
March 18 2022
End Date
May 19 2023
Last Update
August 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070