NCT06010628招募中4 期
Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study
General Hospital of Shenyang Military Region4 个研究点 分布在 1 个国家目标入组 1,440 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,440
- 试验地点
- 4
- 主要终点
- proportion of modified Rankin Scale (mRS) 0-1
研究概览
简要总结
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
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
- Single (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
- •Age ≥ 18 year
- •Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators;
- •The time from last known well to treatment: 4.5 - 6 hours;
- •NIHSS ≥ 4 at randomization;
- •First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
- •Uncertainty over the benefits and risks of thrombolysis by researcher;
- •Signed informed consent.
排除标准
- •Pre-stroke disability (mRS≥2);
- •Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;
- •Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of <100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose < 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures;
- •Pregnancy;
- •Allergy to test drugs;
- •Comorbidity with other serious diseases;
- •Participating in other clinical trials within 3 months;
- •Patients not suitable for the study considered by researcher.
研究组 & 干预措施
Tenecteplase group
Experimental
intravenous thrombolysis with tenecteplase
干预措施: Tenecteplase (Drug)
Control group
Other
standard stroke care based on national guideline
干预措施: Tenecteplase (Drug)
结局指标
主要结局
proportion of modified Rankin Scale (mRS) 0-1
时间窗: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
次要结局
- all-cause mortality(90±7 days)
- intracranial hemorrhage(24 (-6/+12) hours)
- any bleeding event(24 (-6/+12) hours)
- ordinal distribution of modified Rankin Scale (mRS)(90±7 days)
- change in National Institute of Health stroke scale (NIHSS) score(10±2 days)
- occurrence of early neurological improvement (ENI)(24 (-6/+12) hours)
- major systemic bleeding event(24 (-6/+12) hours)
- proportion of modified Rankin Scale (mRS) 0-2(90±7 days)
- symptomatic intracranial hemorrhage (sICH)(24 (-6/+12) hours)
- new stroke or other vascular event(s)(90±7 days)
- change in National Institute of Health stroke scale (NIHSS) score(24 (-6/+12) hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (4)
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