Tenecteplase Before inteRhospital Transfer for Endovascular Treatment in pAtientS With acUte Anterior ciRculation Large vEssel Occlusion at 4.5 to 24 Hours
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 572
- 试验地点
- 3
- 主要终点
- Level of disability (ordinal mRS score)
研究概览
简要总结
This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT).
- Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care
- Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.
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)
盲法说明
Each ECC/nECC will designate one or more physician(s) to perform the follow-up evaluation at 24 (±12) hours, 7 (±2) days or discharge if earlier who cannot be involved in care of the subjects and must remain blinded to treatment assignment. Blinded assessors must undergo a standardized training and competency validation before delegated by the site principal investigator (PI).
Assessment of the primary outcome on the mRS at 90 (±7) days will be performed by a qualified neurologist via structured telephone interview, blinded to both the allocated and actually received treatment. All telephone interviews will be recorded by audio and formed into follow-up reports, which will then be centrally assessed by two experienced and certified physicians. For cases with disagreement between the two assessors, decisions are made by the third experienced neurologist.
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 of 18 years or older;
- •AIS symptom onset to treatment initiation within 4.5 to 24 hours, stroke onset is defined as the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke);
- •Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery (ICA), M1 or proximal M2 vessels;
- •Functionally independent (mRS 0-2) prior to stroke onset;
- •Baseline National Institute of Health Stroke Scale (NIHSS) of 6-25;
- •Intended to transfer to ECCs for EVT (patient transfer), or intended to transfer a neurointerventionalist from the ECC for EVT (physician transfer);
- •Written informed consent from patients or legally authorized representatives;
- •Neuroimaging: large vessel occlusion (ICA, M1, proximal M2) by MRA or CTA AND the target mismatch profile on computed tomography perfusion (CTP) or magnetic resonance perfusion (MRP), defined as an ischemic core volume <70mL, mismatch volume ≥15mL and mismatch ratio ≥1.8;
- •Alternative neuroimaging (if CTP or MRP is technically inadequate or unavailable):
- •An Alberta Stroke Program Early CT Score (ASPECTS) score ≥7 on NCCT or MRI scan;
排除标准
- •Known hypersensitivity or allergy to any ingredients of Tenecteplase;
- •Intended to receive IVT as standard-of-care therapy;
- •Rapidly improving symptoms with NIHSS score <6 before randomization;
- •Any contra-indication for IVT except for the time criterion;
- •Known hereditary or acquired hemorrhagic diathesis;
- •Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, INR >1.7 or prothrombin time >15s; if use of any direct oral anticoagulant within the last 48 hours; if on any full dose heparin/heparinoid within the last 24 hours;
- •Ischemic stroke or myocardial infarction in previous 3 months
- •Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months;
- •Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);
- •Other serious, advanced or terminal illness with life expectancy less than 6 months;
- •Baseline blood glucose <50mg/dl or >400mg/dl;
- •Contraindication to imaging with contrast agents;
- •Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA or MRA (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion);
- •Extensive early ischemic change on non-contrast CT or MRI-DWI estimated to be >1/3 MCA territory, or significant hypodensity outside the Tmax>6s perfusion lesion that invalidates mismatch criteria (if patient is enrolled based on CT perfusion criteria); any CT or MRI findings indicative of a high risk of sICH related to potential intravenous tenecteplase treatment in the judgement of the investigator;
- •Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation;
- •Current participation in another investigational drug or device study;
- •Suspected endocarditis;
- •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 before transfer
Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg. Tenecteplase is for IV administration only. A single bolus dose should be administered over 5 seconds based on patient weight. Transport to ECCs or transfer physician for EVT should be initiated as early as possible after administration according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023.
干预措施: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) (Drug)
Standard of care
Patients will receive standard treatment and be directly transferred to ECCs or transfer physician for EVT according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023.
结局指标
主要结局
Level of disability (ordinal mRS score)
时间窗: at 90 (±7) days
the ordinal score on the modified Rankin scale; The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death).
Ordinal mRS score
时间窗: at 90 (±7) days
the ordinal score on the modified Rankin scale; The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death).
次要结局
- Excellent outcome(at 90 (±7) days)
- Functional independence(at 90 (±7) days)
- Ambulatory and self-care capable(at 90 (±7) days)
- Health-related quality of life(at 90 (±7) days)
- Successful reperfusion(immediately after the endovascular intervention)
- Dichotomized mRS of 0-1 vs. 2-6(at 90 (±7) days)
- Dichotomized mRS of 0-2 vs. 3-6(at 90 (±7) days)
- Dichotomized mRS of 0-3 vs. 4-6(at 90 (±7) days)
- Score on the EQ-5D-5L(at 90 (±7) days)
- Incidence of arterial recanalization(Day 1)
- Recanalization(at 24 (±12) hours)
- First pass reperfusion(intraoperative, immediately after the first pass)