Safety of Intravenous Thrombolytics in Stroke on Awakening (SAIL-ON)
This study is currently recruiting participants.
Verified January 2013 by Johns Hopkins University
Sponsor:
Johns Hopkins University
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 28, 2013
Last verified: January 2013
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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: | July 2014 |
| Estimated Primary Completion Date: | January 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:
|
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
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 | |
| The Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
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 28, 2013 |
| 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 May 16, 2013