NCT07469293尚未招募3 期
Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial
Southwest Hospital, China43 个研究点 分布在 1 个国家目标入组 488 人开始时间: 2026年2月15日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 488
- 试验地点
- 43
- 主要终点
- Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
研究概览
简要总结
DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours;
- •NlHSS score ≥ 5
- •CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction)
- •Patients with premorbid mRS 0 or 1
- •Written informed consent obtained from the participant or a legally authorized representative
排除标准
- •Intracranial hemorrhage confirmed by cranial CT or MRI;
- •Already received intravenous thrombolysis;
- •Planned mechanical thrombectomy;
- •Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;
- •Pregnant or breastfeeding women;
- •Allergy to contrast agents or tenecteplase;
- •Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and failure to control with oral antihypertensive medications;
- •Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR > 1.7, or use of novel oral anticoagulants within 48 hours;
- •Blood glucose < 2.8 mmol/L (50 mg/dL) or > 22.2 mmol/L (400 mg/dL), platelet count < 100 × 10^9/L;
- •History of bleeding within the past month (gastrointestinal or urinary tract bleeding);
- •Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L (2.5 mg/dL));
- •Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia;
- •Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days;
- •Intracranial aneurysms or arteriovenous malformations;
- •Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial;
- •Occlusions in multiple vascular territories confirmed by CTA/MRA;
- •Other reasons that the investigator deems inappropriate for participation in the trial
研究组 & 干预措施
TNK intra-arterial thrombolysis group
Experimental
Intra-arterial thrombolysis
干预措施: Intra-arterial thrombolysis (Procedure)
Standard medical therapy group
Active Comparator
Only standard medical therapy
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
时间窗: At Day 90±7 days
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
次要结局
- Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)(up to 48 hours)
- Improvement in NIHSS between baseline and 5-7 days(at 5-7 days from randomization)
- Distribution of Modified Rankin Scale (mRS)(At Day 90±7 days)
- Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2(At Day 90±7 days)
- EQ-5D-5L score(At Day 90±7 days)
- All-cause mortality(up to 90 days)
研究者
Zhenhua Zhou
Professor
Southwest Hospital, China
研究点 (43)
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