Endovascular Arterial Reperfusion vs. Intravenous ThromboLYsis for Acute Ischemic Stroke (EARLY): A Randomized Pilot Study of Ultra-early (<2 Hours) and Early (2-4.5 Hours) Reperfusion Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Recanalization Rate of Primary Intracranial Occlusion
研究概览
简要总结
This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A randomized trial is justified for the following reasons: 1) The high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in North America without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.
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
- •Age ≥ 18 years
- •Definite or probable ischemic stroke
- •CT angiographic (CTA) evidence of intracranial vascular occlusion (internal carotid, middle cerebral - M1 or M2 divisions, anterior cerebral, posterior cerebral, or basilar artery) within 3.5 hours of symptom onset
- •Able to receive assigned treatment within 4.5 hours of symptom onset
- •Written informed consent from patient or surrogate, if unable to provide consent
排除标准
- •CT evidence of early infarction in >1/3 of middle cerebral artery distribution
- •Blood pressure > 185/110 mmHg refractory to anti-hypertensive therapy
- •History of intracranial hemorrhage
- •History of ischemic stroke within past 3 months
- •History of major surgical procedure within past 14 days
- •Gastrointestinal or genitourinary bleeding within past 14 days
- •Glucose <50 or >400mg/dL
- •Platelet count <100,000
- •International normalized ratio (INR) ≥ 1.7
- •Known history of bleeding diathesis
研究组 & 干预措施
Intravenous Thrombolysis
0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
干预措施: Intravenous Thrombolysis (Drug)
Endovascular Arterial Reperfusion
Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
干预措施: Endovascular Arterial Reperfusion (Device)
结局指标
主要结局
Recanalization Rate of Primary Intracranial Occlusion
时间窗: 24 hours
The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).
次要结局
- Mean Score on Modified Rankin Scale at 90 Days(90 days)