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

March 5, 2017 updated by: Victor C Urrutia, MD, Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Alteplase
  • Activase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 36 hours of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (ESTIMATE)

July 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2017

Last Update Submitted That Met QC Criteria

March 5, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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