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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tPA
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Wake up, IV tPA, Thrombolytic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center
  • The Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV tPA

Arm Description

Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria

Outcomes

Primary Outcome Measures

Number of Participants With Symptomatic Intracerebral Hemorrhage 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
The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6. 0, no symptoms at all. no significant disability despite symptoms; able to carry out all usual duties and activities. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. moderate disability; requiring some help, but able to walk without assistance. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. severe disability; bedridden, incontinent and requiring constant nursing care and attention. dead.

Full Information

First Posted
July 16, 2012
Last Updated
March 5, 2017
Sponsor
Johns Hopkins University
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01643902
Brief Title
Safety of Intravenous Thrombolytics in Stroke on Awakening
Acronym
SAIL-ON
Official Title
Safety of Intravenous Thrombolytics in Stroke on Awakening
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Wake up, IV tPA, Thrombolytic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV tPA
Arm Type
Experimental
Arm Description
Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
Intervention Type
Drug
Intervention Name(s)
tPA
Other Intervention Name(s)
Activase, Alteplase
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment
Description
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.
Time Frame
within 36 hours of treatment
Secondary Outcome Measure Information:
Title
Functional Outcome by the Modified Rankin Scale at 90 Days
Description
The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6. 0, no symptoms at all. no significant disability despite symptoms; able to carry out all usual duties and activities. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. moderate disability; requiring some help, but able to walk without assistance. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. severe disability; bedridden, incontinent and requiring constant nursing care and attention. dead.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor C Urrutia, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29787575
Citation
Urrutia VC, Faigle R, Zeiler SR, Marsh EB, Bahouth M, Cerdan Trevino M, Dearborn J, Leigh R, Rice S, Lane K, Saheed M, Hill P, Llinas RH. Safety of intravenous alteplase within 4.5 hours for patients awakening with stroke symptoms. PLoS One. 2018 May 22;13(5):e0197714. doi: 10.1371/journal.pone.0197714. eCollection 2018.
Results Reference
derived

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Safety of Intravenous Thrombolytics in Stroke on Awakening

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