StrokePhase 2WASSABINCT01455935
Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention
A Phase 2 study testing Anti-platelets and statin, alteplase and intra arterial intervention in people with Stroke, run by Jacobs Neurological Institute at 1 site in United States.
Trial summary
The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Anti-platelets and statin, alteplase and intra arterial intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation:
- Age: 18-80 years old
- Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)
- National Institute of Health Stroke Scale (NIHSS) 8-22
- Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above
- Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)
- Signed informed consent
Who cannot join
- Exclusion Criteria: Potential study patients will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
- Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
- Historical Modified Rankin Scale (mRS) of ≥2
- National Institute of Health Stroke Scale (NIHSS)<8 at the time of treatment
- Positive pregnancy test in women at age of childbearing
- Intracranial or intraspinal surgery within 3 months
Show all 23Show fewer
- Stroke or serious head injury within 3 months
- History of intracranial hemorrhage
- Uncontrolled hypertension at time of treatment (eg, >185 mm Hg systolic or >110 mm Hg diastolic)
- Seizure at the onset of stroke
- Active internal bleeding
- Intracranial neoplasm
- Arteriovenous malformation or aneurysm
- Clinical presentation suggesting post-MI pericarditis
- Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) >1.7
- Internation normalized ratio (INR) >1.7
- Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation
- Platelet count <100,000/mm
- Major surgery within 2 weeks
- GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks
- Aggressive treatment required to lower blood pressure
- Glucose level <50 or >400 mg/dL
- Arterial puncture at a noncompressible site or lumbar puncture within 1 week
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Millard Fillmore Gates Circle Hospital
Buffalo, New York, 14209
Annemarie Crumlish, 716-887-5548, acrumlish@thejni.org
Tareq Kass-Hout, MD
About this study
Official title: Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial
The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.
- Conditions
- Stroke
- Being tested
- Anti-platelets and statin, alteplase, intra arterial intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-platelets and statinDrug
alteplaseDrug
Full dose Intravenous thrombolysis
- 0.9 mg/kg
- Maximum dose is 90 mg
- 10% of the dose will be given over one minute
- 90% of the dose will be infused over 1 hour
- Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
- Neuro checks every 5 minutes during the infusion
- Neuro checks every hour after the infusion for 24 hours
intra arterial interventionProcedure or surgery
- Intra arterial Activase (Maximum dose of 22 mg)
- MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
- PENUMBRA device (no standard time frame for how long the procedure takes)
| Study group | Role | What they receive |
|---|---|---|
| Medical Therapy | Active comparator | Current standard of care per the latest stroke guidelines
* Permissive Hypertension up to 220
* Antipletelets therapy:
1. ASA 81 mg PO daily or
2. Plavix 75 mg PO daily or
3. Aggrenox 225mg PO twice daily
* Anti-inflammatory therapy:
1. Lipitor 80 mg PO daily or
2. Crestor 20 mg PO daily Receives: Drug: Anti-platelets and statin |
| Intravenous Thrombolysis | Experimental | Full dose Intravenous thrombolysis
* 0.9 mg/kg
* Maximum dose is 90 mg
* 10% of the dose will be given over one minute
* 90% of the dose will be infused over 1 hour
* Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
* Neuro checks every 5 minutes during the infusion
* Neuro checks every hour after the infusion for 24 hours Receives: Drug: alteplase |
| Intra-Arterial Therapy | Experimental | -Choice of therapy per experienced Endovascular surgeon and includes:
1. Intra arterial Activase (Maximum dose of 22 mg)
2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
3. PENUMBRA device (no standard time frame for how long the procedure takes) Receives: Procedure: intra arterial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) 90 days post treatment
Measured: 90 days
Secondary outcomes (7)
National Institute of Health Stroke Scale (NIHSS)
National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment.
Measured: 24 hour
National Institute of Health Stroke Scale (NIHSS)
National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)
Measured: 3-29 day
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) at 30 days post treatment
Measured: 30 post treatment
Thrombolysis In Myocardial Infarction (TIMI) Flow
Thrombolysis In Myocardial Infarction (TIMI) flow pre and post the intervention as an indicator of revascularization rate
Measured: Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure
Thomboylsis in Cerebral Ischemia (TICI) flow
Thomboylsis in Cerebral Ischemia (TICI) flow pre and post intervention as an indicator of revascularization rate
Measured: Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure
symptomatic intracranial Hemorrhage (ICH)
Incidence of symptomatic symptomatic intracranial Hemorrhage (ICH) within 72 hours of intervention defined by ECASSIII as 4 points worsening in NIHSS
Measured: 72 hours
National Institute of Health Stroke Scale (NIHSS)
at 30 Day visit National Institute of Health Stroke Scale (NIHSS) will be assessed
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobs Neurological Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo Neurosurgery, Genentech, Inc.
- Responsible party
- Principal investigator, Tareq Kass-Hout, Jacobs Neurological Institute
- Investigators
- Elad I Levy, MD, Study director, University at Buffalo NeurosurgeryTareq Kass-Hout, MD, Principal investigator, Jacobs Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455935
- Sponsor's protocol ID
- NEU 3200411A
- Acronym
- WASSABI
- Status last verified
- Mar 2012
- First submitted
- 7 Oct 2011
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial
- ClinicalTrials.gov ID
- NCT01455935
- Acronym / sponsor ID
- WASSABI / NEU 3200411A
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jacobs Neurological InstituteUniversity, hospital or other
- Collaborators
- University at Buffalo Neurosurgery, Genentech, Inc.
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical Therapy | Active comparator | Drug: Anti-platelets and statinCurrent standard of care per the latest stroke guidelines * Permissive Hypertension up to 220 * Antipletelets therapy: 1. ASA 81 mg PO daily or 2. Plavix 75 mg PO daily or 3. Aggrenox 225mg PO twice daily * Anti-inflammatory therapy: 1. Lipitor 80 mg PO daily or 2. Crestor 20 mg PO daily |
| Intravenous Thrombolysis | Experimental | Drug: alteplaseFull dose Intravenous thrombolysis * 0.9 mg/kg * Maximum dose is 90 mg * 10% of the dose will be given over one minute * 90% of the dose will be infused over 1 hour * Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications * Neuro checks every 5 minutes during the infusion * Neuro checks every hour after the infusion for 24 hours |
| Intra-Arterial Therapy | Experimental | Procedure: intra arterial intervention-Choice of therapy per experienced Endovascular surgeon and includes: 1. Intra arterial Activase (Maximum dose of 22 mg) 2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes) 3. PENUMBRA device (no standard time frame for how long the procedure takes) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation:
- Age: 18-80 years old
- Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)
- National Institute of Health Stroke Scale (NIHSS) 8-22
- Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above
Key exclusion criteria (23 listed)
- Exclusion Criteria: Potential study patients will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
- Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
- Historical Modified Rankin Scale (mRS) of ≥2
- National Institute of Health Stroke Scale (NIHSS)<8 at the time of treatment
- Positive pregnancy test in women at age of childbearing
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 |
|---|---|---|
| Anti-platelets and statin | Drug | Medical Therapy |
| alteplaseFull dose Intravenous thrombolysis * 0.9 mg/kg * Maximum dose is 90 mg * 10% of the dose will be given over one minute * 90% of the dose will be infused over 1 hour * Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications * Neuro checks every 5 minutes during the infusion * Neuro checks every hour after the infusion for 24 hours | Drug | Intravenous Thrombolysis |
| intra arterial intervention1. Intra arterial Activase (Maximum dose of 22 mg) 2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes) 3. PENUMBRA device (no standard time frame for how long the procedure takes) | Procedure or surgery | Intra-Arterial Therapy |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 90 days
Modified Rankin Scale (mRS) 90 days post treatment
7 secondary outcomes
National Institute of Health Stroke Scale (NIHSS)
Time frame: 24 hour
National Institute of Health Stroke Scale (NIHSS)
Time frame: 3-29 day
Modified Rankin Scale (mRS)
Time frame: 30 post treatment
Thrombolysis In Myocardial Infarction (TIMI) Flow
Time frame: Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure
Thomboylsis in Cerebral Ischemia (TICI) flow
Time frame: Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure
symptomatic intracranial Hemorrhage (ICH)
Time frame: 72 hours
National Institute of Health Stroke Scale (NIHSS)
Time frame: 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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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.
Elad I Levy, MD study director
University at Buffalo Neurosurgery
Tareq Kass-Hout, MD principal investigator
Jacobs Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-platelets and statin, alteplase and intra arterial intervention in people with Stroke, run by Jacobs Neurological Institute at 1 site 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 23 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: status not confirmed, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tareq Kass-Hout, MD (716-887-5548, kasshouttareq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2012.