StrokePhase 2SAIL-ONNCT01643902
Safety of Intravenous Thrombolytics in Stroke on Awakening
A Phase 2 study testing tPA in people with Stroke, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- tPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18 years, and lower or equal to 80 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 tPA 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 middle cerebral artery (MCA) territory; or MRI demonstrating no hemorrhage, and with a diffusion-weighted imaging (DWI) lesion no greater than 70 mL 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.
Who cannot join
- Rapidly improving deficit to an NIHSS less than 3.
- Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than 110 mmHg despite treatment.
- Glucose less than 50 mg/dL.
- Stroke or head trauma within last 3 months.
- History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
- Major surgery within 14 days.
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- Gastrointestinal (GI)/Genito-urinary (GU) hemorrhage within 21 days.
- International normalized ratio (INR) > 1.7.
- Heparin within 48 hours with an elevated activated partial thromboplastin time (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 tPA.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (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.
- Conditions
- Stroke
- Being tested
- tPA
- Keywords
- Stroke, Wake up, IV tPA, Thrombolytic
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tPADrug
Also called Activase, Alteplase
IV tPA 0.9 mg/kg maximum 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 door to needle time of 60 minutes or less from ED arrival.
| Study group | Role | What they receive |
|---|---|---|
| IV tPA | Experimental | Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria Receives: Drug: tPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment
Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison.
ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline.
NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage.
Measured: within 36 hours of treatment
Secondary outcomes (1)
Functional Outcome by the Modified Rankin Scale at 90 Days
The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6.
0, no symptoms at all.
- no significant disability despite symptoms; able to carry out all usual duties and activities.
- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
- moderate disability; requiring some help, but able to walk without assistance.
- moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
- severe disability; bedridden, incontinent and requiring constant nursing care and attention.
- dead.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Victor C Urrutia, MD, Johns Hopkins University
- Investigators
- Victor C Urrutia, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643902
- Sponsor's protocol ID
- ML28242
- Acronym
- SAIL-ON
- Status last verified
- Mar 2017
- First submitted
- 16 Jul 2012
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Urrutia VC, Faigle R, Zeiler SR, Marsh EB, Bahouth M, Cerdan Trevino M, Dearborn J, Leigh R, Rice S, Lane K, Saheed M, Hill P, Llinas RH. Safety of intravenous alteplase within 4.5 hours for patients awakening with stroke symptoms. PLoS One. 2018 May 22;13(5):e0197714. doi: 10.1371/journal.pone.0197714. eCollection 2018.
PubMed 29787575
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Intravenous Thrombolytics in Stroke on Awakening
- ClinicalTrials.gov ID
- NCT01643902
- Acronym / sponsor ID
- SAIL-ON / ML28242
- Conditions
- Stroke
- Keywords
- Stroke, Wake up, IV tPA, Thrombolytic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV tPA | Experimental | Drug: tPATreatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater or equal to 18 years, and lower or equal to 80 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 tPA must be initiated prior to 4.5hours from waking up.
- NIHSS >3
Key exclusion criteria (15 listed)
- Rapidly improving deficit to an NIHSS less than 3.
- Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than 110 mmHg despite treatment.
- Glucose less than 50 mg/dL.
- Stroke or head trauma within last 3 months.
- History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tPAAlso: Activase, AlteplaseIV tPA 0.9 mg/kg maximum 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 door to needle time of 60 minutes or less from ED arrival. | Drug | IV tPA |
Primary outcome
Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment
Time frame: within 36 hours of treatment
Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison. ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline. NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage.
1 secondary outcome
Functional Outcome by the Modified Rankin Scale at 90 Days
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29787575Urrutia VC, Faigle R, Zeiler SR, Marsh EB, Bahouth M, Cerdan Trevino M, Dearborn J, Leigh R, Rice S, Lane K, Saheed M, Hill P, Llinas RH. Safety of intravenous alteplase within 4.5 hours for patients awakening with stroke symptoms. PLoS One. 2018 May 22;13(5):e0197714. doi: 10.1371/journal.pone.0197714. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor C Urrutia, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tPA in people with Stroke, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment (time frame: within 36 hours of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.