Safety of Intravenous Thrombolytics in Stroke on Awakening "SAIL-ON"


Phase 2 Results N/A

Eligibility 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.