Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke

Phase 2TerminatedNCT01869478

Mayo Clinic1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Ischemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * International normalized ratio (INR) ≥ 1.7 * Known history of bleeding diathesis

Outcomes

Primary Outcomes

Recanalization Rate of Primary Intracranial Occlusion

The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).

Time frame: 24 hours

Secondary Outcomes

Mean Score on Modified Rankin Scale at 90 Days

Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).

Time frame: 90 days