Effects of Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke: a Randomised, Double-blind, Multicenter, Placebo-controlled Phase 3 Trial (FUTURE-2)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 892
- 主要终点
- Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization.
研究概览
简要总结
This study aims to evaluate the efficacy of Y-6 sublingual tablets in improving microcirculation dysfunction and reducing thrombo-inflammation in patients who had AIS caused by LVO and will receive EVT. Moreover, we expect to evaluate the safety of using Y-6 sublingual tablet in such study population.
This study rationale is based on the following scheme: in patients with acute ischemic stroke caused by LVO, receiving reperfusion therapy may cause futile recanalization and thus lead to microcirculation dysfunction and thrombo-inflammation as consequences. Dexborneol has anti-inflammatory effects and Cilostazol has antiplatelet effects and BBB protection; therefore, the multi-component tablet may exert neuroprotective effects in terms of improving microcirculation dysfunction and reducing thrombo-inflammation in patients with AIS after reperfusion therapy.
The primary purpose of this study is to investigate the proportion of modified-Rankin scale (mRS) score recovered to 0~1 score at 90 days after randomization.
The follow-up duration is 3 months, and the visit schedule is as follows: Subjects enrolled based on randomization procedures will receive visits at screening/baseline period, 1 day, 7 days, 28 days and 90 days after randomization, and in case of any 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 years old ≤ Age ≤ 80 years old;
- •Patients with acute ischemic stroke diagnosed within 24 hours of onset (time from onset to start of endovascular treatment);
- •Patients with first stroke or mRS score 0-1 prior to this onset ;
- •Patients with acute intracranial large vessel occlusion (LVO) confirmed by imaging examination, including occlusion of intracranial segments of internal carotid arteries, T-shaped bifurcation, MCA M1 and/or M2 segments and ACA A1 and/or A2 segments;
- •ASPECTS score ≥ 6 at screening;
- •6<NIHSS score ≤ 25 after this onset;
- •Patients who had the indications for endovascular treatment and were scheduled for endovascular treatment;
- •Patients or his/her legal representatives were able to understand and sign the informed consent.
排除标准
- •Patients who are allergic to the active ingredients or excipients of investigational products；
- •Severe disorder of consciousness at screening: NIHSS 1a consciousness level ≥2 points;
- •Patients with previously diagnosed intracranial haemorrhage at screening, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.;
- •Patients with previously diagnosed intracranial tumor, arteriovenous malformation, or aneurysm at screening;
- •Patients with previously diagnosed congestive heart failure at screening;
- •Patients with bilateral LVO at anterior circulation or LVO at posterior circulation or LVO of unknown aetiology at screening;
- •Patients who have received treatment with warfarin, novel oral anticoagulants, argatroban, snake venom, defibrase, lumbrokinase and batroxobin after onset;
- •Patients with severe hematologic abnormality or severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons at screening (hematologic abnormality was defined as platelet count <100×109/L; severe hepatic insufficiency was defined as ALT > 3 × ULN or AST >3 × ULN; severe renal insufficiency was defined as serum creatinine >3.0 mg/dl (265.2 μmol/L) or creatinine clearance < 30 ml/min);
- •Patients with previously diagnosed hemorrhagic tendency (including but not limited to): hemorrhagic retinopathy or hereditary hemorrhagic disorders, such as hemophilia, at screening;
- •Patients with refractory hypertension that is difficult to be controlled by medication (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg);
- •Patients with history of major head trauma or stroke within 1 month prior to randomization;
- •Patients who have received intracranial or spinal surgery within 3 months prior to randomization;
- •Patients with history of major surgery or serious physical trauma within 1 month prior to randomization;
- •Male subjects (or their mates) or female subjects who had planned to have a child during the whole study period and within 3 months after the end of the study period or were unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, ligation, etc.) during the study period;
- •Patients with contraindications to known contrast agents or other contrast agents;
- •Patients who plan to receive other surgical or intervention therapy within 3 months, which might require discontinuation of the study drugs;
- •Patients with life expectancy of less than 3 months;
- •Patients who have received treatment of investigational drugs or devices within previous 3 months;
- •Other investigator-evaluated conditions which may influence the compliance of patients or where it is not suitable for patients to participate in this trial.
研究组 & 干预措施
Y-6
Take the Y-6 sublingual tablet (each tablet contains 6 mg Dexborneol and 25 mg Cilostazol ), for 28 days continuously.
干预措施: Y-6 (Drug)
Y-6 placebo
Take the placebo of Y-6 sublingual tablet (each tablet contains 0.06 mg Dexborneol and 0 mg Cilostazol ), for 28 days continuously.
干预措施: Y-6 placebo (Drug)
结局指标
主要结局
Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization.
时间窗: 90 days
mRS recover to 0-1
次要结局
- •mRS at 90 days after randomization(90 days)
- • Changes in NIHSS from baseline to 1 day, 7 days and 28 days after randomization；(from baseline to 1 day, 7 days and 28 days)
- • Proportion of patients with early neurological deterioration at 1 day after randomization;(at 1 day)
- • Proportion of subjects with combined vascular events at 90 days after randomization.(90 days)
研究者
yilong Wang
PI，chief physician
Beijing Tiantan Hospital