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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Johns Hopkins University.
Recruitment status was:  Recruiting
Genentech, Inc.
Information provided by (Responsible Party):
Victor C Urrutia, MD, Johns Hopkins University Identifier:
First received: July 16, 2012
Last updated: January 16, 2014
Last verified: January 2014

The primary objective of this study is to evaluate the safety of intravenous tPA in patients waking up with symptoms of acute stroke and presenting to the 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
Drug: rt-PA
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Intravenous Thrombolytics in Stroke on Awakening

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • symptomatic intracerebral hemorrhage [ Time Frame: within 36 hours of treatment ]
    Data on symptomatic intracerebral hemorrhage by using the ECASS 3 criteria as well as the original NINDS IV rt-PA trial criteria for comparison.

Secondary Outcome Measures:
  • Functional outcome. [ Time Frame: 90 days ]
    Evaluate mRankin score, NIHSS, Barthel index at 90 days. (NIHSS also collected at 24 hours)

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV rt-PA
Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
Drug: rt-PA
IV rt-PA 0.9 mg/kg minimum 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 foor to needle time of 60 minutes or less from ED arrival.
Other Names:
  • Activase
  • Alteplase


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age greater or equal to 18 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 rt-PA 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 MCA territory; or MRI demonstrating no hemorrhage, and with a DWI lesion no greater than 70mL 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 185mmHg or diastolic blood pressure greater than 110mmHg despite treatment.
  • Glucose less than 50mg/dL.
  • Stroke or head trauma within last 3 months.
  • History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
  • Major surgery within 14 days.
  • GI/GU hemorrhage within 21 days.
  • INR > 1.7.
  • Heparin within 48 hours with an elevated 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 rt-PA.
  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 identifier: NCT01643902

Contact: Victor C Urrutia, MD 4109552228
Contact: Susan Rice, RN 4106143460

United States, Maryland
Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States
Contact: Alexander Katcheves, MD         
Principal Investigator: Alexander Katcheves, MD         
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Victor C. Urrutia, MD         
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States
Contact: Rafael Llinas, MD         
Principal Investigator: Rafael Llinas, MD         
Sponsors and Collaborators
Johns Hopkins University
Genentech, Inc.
Principal Investigator: Victor C Urrutia, MD Johns Hopkins University
  More Information

Responsible Party: Victor C Urrutia, MD, Assistant Professor, Johns Hopkins University Identifier: NCT01643902     History of Changes
Other Study ID Numbers: ML28242
Study First Received: July 16, 2012
Last Updated: January 16, 2014

Keywords provided by Johns Hopkins University:
Wake up

Additional relevant MeSH terms:
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 processed this record on March 24, 2017