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Safety of Intravenous Thrombolytics in Stroke on Awakening (SAIL-ON)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Victor C Urrutia, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01643902
First received: July 16, 2012
Last updated: March 5, 2017
Last verified: March 2017
  Purpose

The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute stroke.

The hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ED within that time, therefore IV tPA should be safe and effective in this population.


Condition Intervention Phase
Stroke Drug: tPA Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Safety of Intravenous Thrombolytics in Stroke on Awakening

Further study details as provided by Victor C Urrutia, MD, Johns Hopkins University:

Primary Outcome Measures:
  • Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment [ Time Frame: within 36 hours of treatment ]

    Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison.

    ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline.

    NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage.



Secondary Outcome Measures:
  • Functional Outcome by the Modified Rankin Scale at 90 Days [ Time Frame: 90 days ]

    The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6.

    0, no symptoms at all.

    1. no significant disability despite symptoms; able to carry out all usual duties and activities.
    2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
    3. moderate disability; requiring some help, but able to walk without assistance.
    4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
    5. severe disability; bedridden, incontinent and requiring constant nursing care and attention.
    6. dead.


Enrollment: 20
Study Start Date: January 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV tPA
Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
Drug: tPA
IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.
Other Names:
  • Activase
  • Alteplase

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater or equal to 18 years, and lower or equal to 80 years.
  • Signs and symptoms of acute ischemic stroke.
  • Symptoms present upon awakening.
  • Arriving to the Emergency Department within 4.5 hours of awakening. Treatment with IV tPA must be initiated prior to 4.5hours from waking up.
  • NIHSS >3
  • A non-contrast head CT without hemorrhage and without hypodensity more than 1/3 of the middle cerebral artery (MCA) territory; or MRI demonstrating no hemorrhage, and with a diffusion-weighted imaging (DWI) lesion no greater than 70 mL and FLAIR without a well defined hyperintense lesion that is more than 1/3 of the MCA territory.
  • Pre-morbid modified Rankin score of 0 or 1.

Exclusion Criteria:

  • Rapidly improving deficit to an NIHSS less than 3.
  • Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than 110 mmHg despite treatment.
  • Glucose less than 50 mg/dL.
  • Stroke or head trauma within last 3 months.
  • History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
  • Major surgery within 14 days.
  • Gastrointestinal (GI)/Genito-urinary (GU) hemorrhage within 21 days.
  • International normalized ratio (INR) > 1.7.
  • Heparin within 48 hours with an elevated activated partial thromboplastin time (aPTT).
  • Platelet count less than 100,000.
  • Presumed septic embolus or suspicion of bacterial endocarditis.
  • Suspicion of aortic dissection.
  • Use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin.
  • Pregnant or lactating women.
  • Known allergy or sensitivity to tPA.
  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: NCT01643902

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Genentech, Inc.
Investigators
Principal Investigator: Victor C Urrutia, MD Johns Hopkins University
  More Information

Responsible Party: Victor C Urrutia, MD, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01643902     History of Changes
Other Study ID Numbers: ML28242
Study First Received: July 16, 2012
Results First Received: January 19, 2016
Last Updated: March 5, 2017

Keywords provided by Victor C Urrutia, MD, Johns Hopkins University:
Stroke
Wake up
IV tPA
Thrombolytic

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2017