TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Randomized, Double-blind, Double-dummy Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,386
- 试验地点
- 1
- 主要终点
- Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.
详细描述
This study is a multicenter, prospective, randomized, double-blind, double-dummy controlled (2 arms with 1:1 randomization) trial. Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) will be enrolled. Eligible patients must have neurological deficits involving at least language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg, plus placebo oral aspirin and clopidogrel. Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic therapy. Control group: Dual antiplatelet therapy with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel will be given within 6 ± 2 hours following the placebo thrombolytic therapy.The primary endpoint is an excellent functional outcome (a modified Rankin Scale score of 0-1) at 90-day.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aspirin combined with clopidogrel
Aspirin 100mg combined with clopidogrel 300mg, plus placebo intravenous rhTNK-tPA
干预措施: Control group (Aspirin combined with clopidogrel) (Drug)
rhTNK-tPA (0.25 mg/kg)
rhTNK-tPA (0.25 mg/kg, max 25 mg) with placebo oral aspirin and clopidogrel
干预措施: rhTNK-tPA (Drug)
结局指标
主要结局
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).
时间窗: at 90-day (± 7 days)
Modified Rankin Scale score, mRS 0-1
次要结局
- Good functional outcome (mRS 0-2) at 90-day (± 7 days)(at 90-day (± 7 days))
- mRS score at 90-day (± 7 days)(at 90-day (± 7 days))
- COSMOS Scale 0-1 at 90-day (±7days)(90-day± 7days)
- COSMOS scale at 90-day (±7 days)(90-day± 7days)
- Total mortality within 90-day (± 7 days)(within 90-day (± 7 days))
- NIHSS 0-1 at 24-hour, 7-day or before discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥4 from baseline)(at 24-hour, 7-day or before discharge (analyze which occurs first))
- Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 7 days or before discharge.(within 7 days or before discharge)
- Neurological deterioration at 90 days(90-day (±7 days))
- New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated.(at 90-day (± 7 days))
- Adverse events/Severe adverse events within 90-day (± 7 days)(within 90-day (± 7 days))
- European quality of life visual analogue scale at 90 days(at 90-day (± 7 days))
- Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 36-hour.(within 36-hour)
- Any intracranial hemorrhage within 90-day (± 7 days)(within 90-day (± 7 days))
- Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 90-day (± 7 days)(within 90-day (± 7 days))
- PH2 type intracranial hemorrhage according to the Heidelberg criteria within 90-day (± 7 days)(within 90-day (± 7 days))
- Severe bleeding events according to the GUSTO criteria within 90-day (± 7 days)(within 90-day (± 7 days))
研究者
Yongjun Wang
professor
Beijing Tiantan Hospital