Feasibility Study of IV rtPA vs. Primary Endovascular Therapy for Acute Ischemic Stroke
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 12-002496
Sponsor Protocol Number: 12-002496
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 |
|
More information
Publications
Publications are currently not available