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

Primary Purpose

Stroke, Ischemic Stroke

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous Thrombolysis
Endovascular Arterial Reperfusion
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravenous Thrombolysis

Endovascular Arterial Reperfusion

Arm Description

0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.

Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
June 1, 2013
Last Updated
August 12, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01869478
Brief Title
Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Thrombolysis
Arm Type
Active Comparator
Arm Description
0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
Arm Title
Endovascular Arterial Reperfusion
Arm Type
Active Comparator
Arm Description
Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
Intervention Type
Drug
Intervention Name(s)
Intravenous Thrombolysis
Other Intervention Name(s)
Altelplase, rtPA
Intervention Type
Device
Intervention Name(s)
Endovascular Arterial Reperfusion
Other Intervention Name(s)
Penumbra, Solitaire
Primary Outcome Measure Information:
Title
Recanalization Rate of Primary Intracranial Occlusion
Description
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 Outcome Measure Information:
Title
Mean Score on Modified Rankin Scale at 90 Days
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin M Barrett, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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