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

This study has been terminated.
(Poor recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01869478
First Posted: June 5, 2013
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kevin M. Barrett, M.D., Mayo Clinic
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Kevin M. Barrett, M.D., Mayo Clinic:

Primary Outcome Measures:
  • Recanalization Rate of Primary Intracranial Occlusion [ Time Frame: 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:
  • Mean Score on Modified Rankin Scale at 90 Days [ Time Frame: 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).


Enrollment: 1
Study Start Date: January 2013
Study Completion Date: September 2015
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • International normalized ratio (INR) ≥ 1.7
  • Known history of bleeding diathesis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869478


Locations
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kevin M Barrett, MD Mayo Clinic
  More Information

Responsible Party: Kevin M. Barrett, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01869478     History of Changes
Other Study ID Numbers: 12-002496
First Submitted: June 1, 2013
First Posted: June 5, 2013
Results First Submitted: August 12, 2016
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action