Safety of Intravenous Thrombolytics in Stroke on Awakening

Stroke Clinical Trial

— SAIL-ON  

Official title:

Safety of Intravenous Thrombolytics in Stroke on Awakening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01643902
• Other study ID #: ML28242
• Status: Recruiting
• Phase: Phase 2
• First received: July 16, 2012
• Last updated: January 16, 2014
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Johns Hopkins University
• Contact: Victor C Urrutia, MD
• Phone: 4109552228
• Email: vurruti1[@]jhmi.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic intracerebral hemorrhage	Data on symptomatic intracerebral hemorrhage by using the ECASS 3 criteria as well as the original NINDS IV rt-PA trial criteria for comparison.	within 36 hours of treatment	Yes
Secondary	Functional outcome.	Evaluate mRankin score, NIHSS, Barthel index at 90 days. (NIHSS also collected at 24 hours)	90 days	No