Feasibility Study of IV rtPA vs. Primary Endovascular Therapy for Acute Ischemic Stroke
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | September 2015 |
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
This pilot trial will be the first step toward direct comparison of delivery of endovascular
reperfusion therapy to intravenous 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.
reperfusion therapy to intravenous 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- INR ≥ 1.7
- Known history of bleeding diathesis
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