Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- recanalization rate
研究概览
简要总结
Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90% with last generation devices. A recent meta-analysis has shown that the best candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is increased in association with antiplatelets such as abciximab. The aim of the study was to assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical trial versus the gold standard for acute ischemic stroke revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms 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
- 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 signs consistent with acute ischemic stroke < 4.5 hours
- •Cerebral infarction and middle cerebral artery occlusion, without any hemorrhage documented by MRI or CT
- •4 < National Institute of Health Stroke Score (NIHSS) < 25
- •age > 18 years
- •no prestroke functional dependance : modified Rankin score ≤ 2
- •subject or subject's legally authorized representative has signed and dated an Informed Consent Form according to french regulations and ethic committee.
排除标准
- •pregnant or lactating female
- •coma (vigilance NIHSS > 1)
- •recent history of stroke
- •anticoagulant therapy or International Normalized Ratio (INR) > 1.7 ; heparin therapy within past 24 hours and Temps de Cephaline Activee (TCA) extension
- •previous subarachnoid hemorrhage or clinical presentation suggesting a subarachnoid hemorrhage, even if initial CT or MRI scan are normal
- •known hereditary or acquired hemorrhagics diathesis, coagulation factor deficiency
- •uncontrolled hypertension defined as systolic blood pressure ≥ 185 millimeters of mercury (mmHg) or diastolic blood pressure > 110 mmHg at time of admission and time of threat
- •lumbar ar arterial puncture within past 7 days
- •major surgery within past 2 months
- •gastrointestinal hemorrhage or urinary hemorrhage
- •myocardial infarction within past 21 days
- •pericarditis within past 3 months
- •suspicion of bacterial endocarditis within past 3 months
- •previous of aortic dissection
- •baseline lab values : TCA > 40, platelets < 100 000/mm3, glucose < 3 mmol/l or > 22 mmol/l
- •hepatic insufficiency
- •CT or MRI evidence oh hemorrhage
- •CT or MRI evidence of mass effect or intra-cranial tumor
- •CT showing hypodensity or MRI showing hyperdensity involving greater than 1/3 of the middle cerebral artery territory (ASPECT score < 7)
研究组 & 干预措施
abciximab IV and thrombectomy
abciximab IV (0.25mg/kg by IV bolus, following by 0.125μg/kg by 12 hours IV drip) and thrombectomy
干预措施: abciximab IV and thrombectomy (Procedure)
alteplase
alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)
干预措施: alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) (Drug)
结局指标
主要结局
recanalization rate
时间窗: 24 hours
次要结局
- Symptomatic intracranial bleeding(24 hours)
- percentage of patients with a favorable outcome(3 months)