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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Kevin M. Barrett, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01869478
First received: June 1, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Ischemic Stroke
Drug: Intravenous Thrombolysis
Device: Endovascular Arterial Reperfusion
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Recanalization rate of primary intracranial occlusion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour CTA.


Secondary Outcome Measures:
  • modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS)


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Intravenous Thrombolysis
Other Name: Altelplase, rtPA
Active Comparator: 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.
Device: Endovascular Arterial Reperfusion
Other Name: Penumbra, Solitaire

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • INR ≥ 1.7
  • Known history of bleeding diathesis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869478

Locations
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Sothear Luke, MPH       luke.sothear@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kevin M Barrett, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Kevin M. Barrett, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01869478     History of Changes
Other Study ID Numbers: 12-002496
Study First Received: June 1, 2013
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014