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

Phase 2

Terminated

• Conditions: Ischemic Stroke; Stroke
• Interventions: Device: Endovascular Arterial Reperfusion; Drug: Intravenous Thrombolysis

• Registration Number: NCT01869478
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-01
• Study First Submitted QC: 2013-06-01
• Study First Posted: 2013-06-05
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-08
• Results First Submitted: 2016-08-12
• Results First Submitted QC: 2016-08-12
• Last Update Submitted: 2016-08-12
• Results First Posted: 2016-10-05
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular Arterial Reperfusion	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.
Intravenous Thrombolysis	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.

Primary Outcome Measures

Name	Time	Method
Recanalization Rate of Primary Intracranial Occlusion	24 hours	The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).

Secondary Outcome Measures

Name	Time	Method
Mean Score on Modified Rankin Scale at 90 Days	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).

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States