NCT05624190招募中4 期
Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator rhTNK-tPA) Thrombolysis for Acute Large Vessel Occlusion After Successful Mechanical Thrombectomy Recanalization -- A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial (ANGEL-TNK)
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2023年2月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Rate of excellent outcome
研究概览
简要总结
The goal of this clinical trial is to evaluate whether intra-arterial (IA) rhTNK-tPA thrombolysis can improve neurological outcomes in acute large vessel occlusion patients after successful mechanical thrombectomy (MT) recanalization between 4.5- 24 hours from symptom onset. Participants enrolled will be randomly assigned to study or control arm with a 1:1ratio. Study group will receive IA rhTNK-tPA thrombolysis (0.125 mg/kg, Max 12.5mg) plus best medical management, and control receive best medical management alone.
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
- •Clinical Inclusion Criteria:
- •Age >18 years;
- •Onset of symptoms to baseline CT imaging time: 4.5 to 24 hours, including wake-up stroke and unwitnessed stroke; Time of onset of symptoms is defined as "last known well" (LKW);
- •Pre-stroke mRS score 0-1;
- •Signed informed consent from patient or their health care proxy.
- •Neuroimaging Inclusion Criteria:
- •CTA/MRA proven intracranial artery occlusion: Intracranial Internal Carotid Artery (ICA)、M1 of Middle cerebral artery (MCA)、dominant M2 of MCA;
- •ASPECTS ≥6 on non-contrast CT (NCCT) scan or DWI MRI;
- •CT perfusion or MR perfusion: ischemic infarct core <70ml, mismatch ratio≥1.2, mismatch volume ≥15ml;
- •Treated with MT resulting in an eTICI score 2b50-3 at end of the procedure. Patients with an eTICI score 2b50-3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
排除标准
- •Clinical Exclusion Criteria:
- •IV thrombolysis used on admission;
- •Contraindications to intravenous thrombolysis;
- •Balloon angioplasty, permanent stenting and other situations during the endovascular procedure that require antiplatelet therapy or anticoagulant within the first 24h;
- •IV heparin (heparinized saline allowed);
- •Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
- •Brain tumor (with mass effect);
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- •Known coagulopathy, INR>1.7 or use of novel anticoagulants < 48h from symptom onset
- •Platelets < 50*109/L;
- •Suspicion of septic emboli or endocarditis
- •Renal Failure as defined by a serum creatinine > 2.5 mg/dl (or 220μmol/l) or glomerular Filtration Rate [GFR] < 30ml/min;
- •Patient who requires hemodialysis or peritoneal dialysis, or who has a contraindication to angiogram for whatever reason;
- •Suspicion of aortic dissection;
- •Parenchymal organ surgery and biopsy were performed in the past one month;
- •Any active bleeding or recent bleeding (gastrointestinal bleeding, urinary bleeding, etc.) in the past 1 month;
- •History of life-threatening allergy (more than rash) to contrast medium;
- •SBP >185 mmHg or DBP >110 mmHg refractory to treatment;
- •Serious, advanced, terminal illness with anticipated life expectancy < 6 months;
- •Participation in another randomized clinical trial that could confound the evaluation of the study;
- •Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients (e.g. inability to understand and/or comply with study procedures and/or follow-up due to mental disorders, cognitive or mood disorders).
- •Specific Neuroimaging Exclusion Criteria
- •Midline shift or herniation, mass effect with effacement of the ventricles
- •Evidence of acute intracranial hemorrhage on CT/MRI
- •Acute bilateral strokes or multiple intracranial vessel occlusions
- •Isolated extracranial ICA occlusion or tandem carotid / MCA occlusion
- •Dissection of occluded artery on DSA after thrombectomy
研究组 & 干预措施
TNK group
Experimental
Patients of this group will receive IA rhTNK-tPA plus Best Medical Management (BMM) after successful mechanical thrombectomy (MT) recanalization
干预措施: Recombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) (Drug)
TNK group
Experimental
Patients of this group will receive IA rhTNK-tPA plus Best Medical Management (BMM) after successful mechanical thrombectomy (MT) recanalization
干预措施: Best Medical Management (Other)
control group
Active Comparator
Patients of this group will receive Best Medical Management (BMM) alone after successful mechanical thrombectomy (MT) recanalization
干预措施: Best Medical Management (Other)
结局指标
主要结局
Rate of excellent outcome
时间窗: 90±7 days after randomization
Rate of 90 (±7) day modified Rankin scale (mRS) 0-1
次要结局
- Infarct core volume change from baseline(7 days (±1 day) after randomization/at discharge or at 36 hours (±12 hours) after randomization)
- mRS (shift analysis)(90 days (±7 days) after randomization)
- All-caused mortality(90 days (±7 days) after randomization)
- Rate of sICH (Heidelberg Bleeding Classification)(within 48 hours after randomization)
- Rate of good outcome(90 days (±7 days) after randomization)
- NIHSS 0-1 or decrease ≥10 from baseline NIHSS(36 hours (±12hours) after randomization)
- EQ-5D-5L score(90 days (±7 days) after randomization)
- Rate of mRS 0-3(90 days (±7 days) after randomization)
- Volume of Tmax>6s(24 hours (±12 hours) after randomization)
- Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification)(within 48 hours after randomization)
研究者
Zhongrong Miao
Director of Department of interventional neurology
Beijing Tiantan Hospital
研究点 (1)
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