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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Johns Hopkins University
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Victor C Urrutia, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01643902
First received: July 16, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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
Stroke
Drug: rt-PA
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01643902

Contacts
Contact: Victor C Urrutia, MD 4109552228 vurruti1@jhmi.edu
Contact: Susan Rice, RN 4106143460 smrice@jhmi.edu

Locations
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
Investigators
Principal Investigator: Victor C Urrutia, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Victor C Urrutia, MD, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01643902     History of Changes
Other Study ID Numbers: ML28242
Study First Received: July 16, 2012
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Stroke
Wake up
IV tPA
Thrombolytic

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014