Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5 Improving Neurological Functional Outcomes in Basilar Artery Occlusion With Tenecteplase in Extended Time Window: Multicentre, Prospective, Open-label, Blinded Endpoint (PROBE), Phase 3, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 试验地点
- 59
- 主要终点
- Modified Rankin Scale (mRS) 0-1 or return to baseline mRS
研究概览
简要总结
The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting within 24 hours will be randomized 1:1 to intravenous tenecteplase (0.25mg/kg, maximum 25mg) ± thrombectomy or 'best practice'which may be alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion.
详细描述
The study will be a multicentre, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial (2 arm with 1:1 randomization) in patients with acute ischemic stroke due to basilar artery occlusion presenting to hospital within 24 hours of symptom onset.
Patients will be required to have complete or near-complete occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA), defined as 'potentially retrievable' thrombus in the basilar artery. Thrombectomy is permitted within 24 hours as part of standard care but is not mandatory.
Patients will be randomized to treatment with either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg within 4.5 hours from stroke onset) or intravenous tenecteplase (0.25mg/kg, maximum 25mg). Time of onset of symptoms is defined as described by the patient or witness; if unknown, it is considered to be the last time the patient was seen well. In patients presenting with mild (e.g. vertigo, dizziness, headache, diplopia, dysarthria) stuttering symptoms followed by sudden onset of clinical deterioration with decrease in conscious state or moderate to severe motor deficits, the time of deterioration in clinical state is taken as the estimated time of basilar artery occlusion.
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
- •Patients presenting with posterior circulation ischemic stroke symptoms due to near-complete or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well.
- •Presence of a basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a near or complete occlusion.
- •Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
- •Local legal requirements for consent have been satisfied.
排除标准
- •Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
- •Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) <6 on non-contrast CT (NCCT) or CTA-source images or MRI diffusion weighted imaging (DWI).
- •Significant cerebellar mass effect or acute hydrocephalus.
- •Established frank hypodensity on non-contrast CT indicating subacute infarction.
- •Bilateral extensive brainstem ischemia.
- •Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
- •Other standard contraindications to intravenous thrombolysis.
- •Contraindication to imaging with contrast agents.
- •Clinically evident pregnant women.
- •Vessel imaging showing both anterior and posterior circulation large vessel occlusion.
- •Current participation in another research drug treatment protocol.
- •Known terminal illness such that the patients would not be expected to survive a year.
- •Planned withdrawal of care or comfort care measures.
- •Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
研究组 & 干预措施
Tenecteplase
Intravenous tenecteplase (0.25mg/kg, maximum 25mg) within 24 hours ± thrombectomy at treating clinician's discretion
干预措施: Tenecteplase (Drug)
Best Practice (which may include intravenous Alteplase)
Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
干预措施: Best Practice (which may include intravenous Alteplase) (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS) 0-1 or return to baseline mRS
时间窗: 3 months
The proportion of patients with Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS (if baseline premorbid mRS =2-3) at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
次要结局
- Modified Rankin Scale (mRS) 0-2 or return to baseline mRS(3 months)
- Modified Rankin Scale (mRS) 0-3 or return to baseline mRS(3 months)
- Ordinal analysis of the Modified Rankin Scale (mRS)(3 months)
- Early neurological improvement(72 hours)
- Successful reperfusion(initial DSA run prior to thrombectomy)
- Symptomatic intracranial hemorrhage (sICH)(36 hours)
- All-cause mortality(90 days)
- Severe disability or death(90 days)
- Clinical deterioration(24 hours)
- Vessel recanalization(24+/-6 hours)
研究者
Yongjun Wang
professor
Beijing Tiantan Hospital