NCT04516993已完成2 期
Prospective, Multicenter, Open, End-point Blinded, Stratified Block Randomized, Parallel Positive Controlled Clinical Trial of Tenecteplase in Acute Ischemic Stroke With Large Vessel Occlusion Over Time Window
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- patients without endovascular therapy obtained >50% reperfusion at 4-6 hours
研究概览
简要总结
To explore the efficacy and safety of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with anterior circulation acute ischaemic stroke
- •Time from onset to treatment 4.5h-24h
- •Patient's age is >= 18 years，<= 80
- •Pre-stroke mRS score of <= 2
- •Clinically significant acute neurologic deficit
- •Baseline National Institute of Health stroke scale >= 6
- •Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
- •Multimodal CT/magnetic resonance imaging: perfusion lesion volume (DT > 3 s) to infarct core volume ratio (rCBF<30% or diffusion-weighted imaging lesion) >1.2, absolute difference >10 ml, and ischemic core volume <70ml
- •Informed consent was obtained from patients.
排除标准
- •Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
- •Rapidly improving symptoms (patient with an NIHSS score decrease to < 4 at randomization)
- •Pre-stroke mRS score of > 2
- •Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
- •Infarct core >1/3 middle cerebral artery (MCA) territory
- •Platelet count < 100x10^9/L
- •Symptoms were caused by low blood glucose < 2.7 mmol/l
- •Severe uncontrolled hypertension, i.e. systolic blood pressure >= 180 mmHg or diastolic blood pressure >=100 mmHg
- •Current use of warfarin with a prolonged prothrombin time (INR > 1.7 or prothrombin time > 15s)
- •Use of low molecular weight heparin within 24 hours
- •Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
- •Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
- •Arterial puncture at noncompressible site in previous 7 days
- •Major surgery in previous 14 days which poses risk in the opinion of the investigator
- •Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
- •Significant head trauma or prior stroke in previous 3 months
- •History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
- •Hereditary or acquired haemorrhagic diathesis
- •Active internal bleeding
- •Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
- •Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
- •Pregnancy or lactation
- •Various dying diseases with life expectancy ≤3 months
- •Other conditions in which doctors believe that participating in this study may be harmful to the patient
- •Patients participated in any trial in 30 days
- •Allergic to the test drug and its ingredients
研究组 & 干预措施
Tenecteplase arm
Experimental
干预措施: Tenecteplase (Drug)
Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Other
The best treatment selected by local doctors
干预措施: The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) (Drug)
结局指标
主要结局
patients without endovascular therapy obtained >50% reperfusion at 4-6 hours
时间窗: 4-6 hours
Without endovascular therapy: \>50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours
patients with endovascular therapy: mTICI score 2b or better at initial angiogram
时间窗: Before endovascular therapy
With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy
no symptomatic intracranial hemorrhage at 24-36 hours
时间窗: 24-36 hours
No symptomatic intracranial hemorrhage at 24-36 hours
次要结局
- Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours(24-36 hours)
- Clinical safety outcome: Rate of systemic bleeding(90 days (plus or minus 7 days))
- Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours(24-36 hours)
- Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours(24-36 hours)
- Clinical safety outcome: death within 90 days(90 days (plus or minus 7 days))
- Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography(4-6 hours)
- Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion(3-5 days)
- Clinical efficacy outcome: percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)(90 days (plus or minus 7 days))
- Clinical efficacy outcome: incident event(90 days (plus or minus 7 days))
- Clinical efficacy outcome: NIHSS change(24 hours (plus or minus 2 hours))
- Clinical efficacy outcome: percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days)(90 days (plus or minus 7 days))
- Barthel index(90 days (plus or minus 7 days))
- Imaging efficacy outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours(4-6 hours)
- Imaging efficacy outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram(Before endovascular therapy)
- Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days(3-5 days)
- Clinical efficacy outcome: NIHSS change at 7 days(7 days (plus or minus 2 days))
- Clinical efficacy outcome: vascular death within 90 days(90 days (plus or minus 7 days))
- Clinical efficacy outcome: major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)(24-36 hours)
研究者
Qiang Dong
Director of Neurology Department
Huashan Hospital
研究点 (1)
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