Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 2
- 主要终点
- mRS ≤ 2 at 90 days or no change from baseline
研究概览
简要总结
A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging mechanical thrombectomy.
详细描述
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) is a phase III, multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial. Randomization will be 1:1 according to reperfusion treatment modalities: (A) Intravenous thrombolysis with tenecteplase (0.25 mg/kg) plus mechanical thrombectomy vs. (B) Intravenous thrombolysis with alteplase (0.9 mg/kg) plus mechanical thrombectomy. For the primary outcome, the subjects will be followed up within 90 days after randomization. The primary outcome will be the Functional independence defined as modified Rankin Score ≤ 2.
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
- •Age is ≥18 years.
- •AIS symptom onset ≤4.5 hours, onset time refers to the time the patient was last known to be well. (Recommendation time from thrombolysis to puncture within 60 minutes).
- •Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
- •Prestroke mRS score ≤
- •Informed consent from the patient or legally authorised representative.
排除标准
- •Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other related conditions identified by CT.
- •Contraindication to imaging examinations involving contrast agent injection.
- •Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3).
- •History of intracranial hemorrhage.
- •History of severe head trauma or stroke within the past 3 months.
- •Intracranial or intraspinal surgery within the past 3 months.
- •Major surgery within the past 2 weeks.
- •Gastrointestinal or urinary tract bleeding within the past 3 weeks.
- •Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm.
- •Active visceral bleeding.
- •Aortic arch dissection.
- •Arterial puncture at a non-compressible site within the past week.
- •Uncontrolled hypertension despite active antihypertensive treatment: Systolic Blood Pressure > 180 mmHg or Diastolic Blood Pressure > 100 mmHg.
- •Acute hemorrhagic tendency, including platelet count < 100 × 10⁹/L or other conditions.
- •Heparin treatment received within the past 24 hours.
- •For patients on oral anticoagulants: INR > 1.7 or PT > 15 seconds.
- •Use of direct thrombin inhibitors or direct Factor Xa inhibitors within the past 48 hours.
- •Blood glucose < 2.8 mmol/L or > 22.2 mmol/L.
- •Hypodensity affecting > 1/3 of the middle cerebral artery territory or an equivalent proportion of the basilar artery territory on non-contrast CT.
- •Rapidly improving symptoms as determined by the investigator.
- •Participation as a subject in another research study within the past 30 days.
- •Any terminal illness where life expectancy is considered not to exceed 1 year.
- •Any condition where, in the judgment of the investigator, the study treatment might pose a risk to the patient or affect the patient's participation in the study.
- •Pregnant women.
- •Known allergy to the active ingredients (Alteplase, Tenecteplase) or any excipients.
研究组 & 干预措施
tenecteplase
Subjects assigned to this arm will receive an intravenous bolus of 0.25mg/kg tenecteplase before the mechanical thrombectomy.
干预措施: Tenecteplase (Drug)
alteplase
Subjects assigned to this arm will receive an intravenous 0.9 mg/kg alteplase(10% bolus +90% infusion/1 hour) before the mechanical thrombectomy.
干预措施: Alteplase (Drug)
结局指标
主要结局
mRS ≤ 2 at 90 days or no change from baseline
时间窗: 90 days from baseline
mRS ≤ 2 at 90 days or no change from baseline
次要结局
- mTICI 2b/3 or absence of retrievable thrombus at initial angiogram(initial angiogram)
- mRS at 90 days from baseline(90 days from baseline)
- mRS 0-1 at 90 days or no change from baseline(90 days from baseline)
- Barthel index at 90 days from baseline(90 days from baseline)
- NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline(3 days from baseline)
- Change of NIHSS at 1、3、7 days from baseline(1、3、7 days from baseline)