Feasibility Study of IV rtPA vs. Primary Endovascular Therapy for Acute Ischemic Stroke

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Kevin Barrett, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Kevin Barrett, M.D.

Closed for enrollment

More information

Publications

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