Treatment of Acute Ischemic STroke With Edaravone Dexborneol Ⅱ (TASTE-2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,362
- 试验地点
- 1
- 主要终点
- Favorable functional outcome
研究概览
简要总结
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 patients with acute ischemic stroke who had received early reperfusion therapy.
详细描述
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 had received early reperfusion therapy. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio after the ICF was received. Patients in one arm will be given 15 ml edaravone and dexborneol concentrated solution for injection (37.5 mg, containing edaravone 30 mg and dexborneol 7.5 mg) twice a day for 10-14 days, and those in the other arm will be given an equivalent placebo drug. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2 and the safety outcome is the proportion of severe adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Edaravone Dexborneol group
Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.
干预措施: Edaravone Dexborneol Concentrated Solution for injection (Drug)
Edaravone Dexborneol Placebo group
Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days.
干预措施: Edaravone Dexborneol placebo (Drug)
结局指标
主要结局
Favorable functional outcome
时间窗: at 90 days after randomization
Rate of favorable functional outcome defined as a modified Rankin Scale (mRS, scores range from 0 to 6, with 0 to 2 indicating favorable outcome and 3 to 6 indicating unfavorable outcome including 6 as death) score of 0-2
Incidence of severe adverse event (Safety outcome)
时间窗: at 90 days after randomization
The incidence of Severe Adverse Event (SAE) emerged during the whole study period
次要结局
- NIHSS score decreases ≥4(at 10-14 days after randomization)
- Excellent functional outcome(at 90 days after randomization)
- NIHSS score change(at 10-14 days after randomization)
- Symptomatic intracranial hemorrhage (sICH)(at 24-36 hours after randomization)
- Adverse events (AE)(within 90 days after randomization)
- All-cause mortality(at 90 days after randomization)
- Neurological deterioration(at day 1 after randomization)
- Stroke recurrence(within 90 days after randomization)
研究者
Yongjun Wang
President of Beijing Tiantan Hospital, Capital Medical University
Beijing Tiantan Hospital