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

Stroke Clinical Trial

— EARLY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869478
• Other study ID #: 12-002496
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2013
• Last updated: September 23, 2015
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Intravenous Thrombolysis

Device:
• Endovascular Arterial Reperfusion

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recanalization rate of primary intracranial occlusion	The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour CTA.	24 hours	No
Secondary	modified Rankin Scale	Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS)	90 days	No