Safety of Intravenous Thrombolytics in Stroke on Awakening

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tPA

Drug

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

Primary outcomes

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 outcomes

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.
- 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

Genentech, Inc.

Registry information

Acronym: SAIL-ON

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 18, 2012
Registry last updated: Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed