Ischemic StrokePhase 1AWOKENCT01150266
Study for the Use of Alteplase in Patients Who Awaken With Stroke
A Phase 1 study testing Alteplase (tPA) in people with Ischemic Stroke, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present with stroke symptoms upon awakening. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Alteplase (tPA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2013
- Phase
- Phase 1
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥22
- Stroke upon awakening
- Measurable deficit by NIHSS
- No deficit before sleep or last seen normal before to sleep
- Head CT with no evidence of intracranial hemorrhage.
- Able to receive IV t-PA treatment within 2.5 hrs after patient awoke with deficit.
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- Written informed consent signed and dated by the patient (or patient's authorized representative)
- Core lesion: ASPECTS ≥7 on MRI-DWI, CTP-CBV or CTA source imaging.
- Mismatch of at least 20% measured by CT CVB/MMT or DWI/TTP
Who cannot join
- Stroke or serious head trauma within the preceding 3 months
- Major surgery or serious trauma within 14 days
- History of intracranial hemorrhage
- Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures.
- Rapidly improving or minor symptoms
- Symptoms suggestive of subarachnoid hemorrhage.
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- Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days.
- Arterial puncture at a non-compressible site within the previous 7 days
- Seizure at the onset of stroke and considered the cause for the neurological symptom.
- Patients who are taking anticoagulants or who had received heparin within the 48 hours preceding the onset of stroke and have an elevated partial-thromboplastin time, INR>1.7 or platelet counts below 100,000/mm3
- Finger sticks glucose below 50 mg/dl (2.7 mmol/ Lt) or above 400 mg per deciliter (22.2 mmol/Lt) and considered the cause for the neurological symptom.
- Active internal bleeding
- Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy).
- Lumbar puncture within 7 days.
- Known co-morbid conditions likely to complicate therapy or interfere with patient assessment, such us: heart failure stage 4, severe dementia, end-stage AIDS, pericarditis, cirrhosis or known cancer.
- Unable to obtain CTA or perfusion brain studies (PWI or CTP)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92037-0979
About this study
Official title: Alteplase for Waking Onset STROKE
This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present with stroke symptoms upon awakening.
Read the detailed description
Patients with ischemic stroke are currently only eligible for the treatment with intravenous thrombolysis if the stroke is diagnosed within 4.5 hours from known onset of symptoms.
Many patients awaken with stroke and are excluded from this therapy, following current guidelines.
Patients who suffer from a stroke just before or after waking up may be candidates for thrombolysis and our study will use advanced neuroimaging to select those patients.
- Conditions
- Ischemic Stroke
- Being tested
- Alteplase (tPA)
- Keywords
- stroke, ischemia, thrombolysis, thrombolytics, tPA, rt-PA, t-PA, Activase®, Alteplase, wake-up stroke, waking onset stroke, sleep
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteplase (tPA)Drug
Also called Activase®, rt-PA, t-PA, tPA
0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
| Study group | Role | What they receive |
|---|---|---|
| Alteplase | Experimental | Alteplase 0.9mg/kg (maximum 90mg), 10% IV bolus over 1 minute and the remainder over one hour infusion in patients with ischemic stroke after awaking. Receives: Drug: Alteplase (tPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Intracranial Hemorrhage
sICH is defined as any confluent dense hematoma occupying greater than 30% of the infarcted area with substantial space occupying effect, or any brain hemorrhage outside the infarcted area that occurs within 72 hours of tPA treatment and is associated with an increase of at least 4 points in the NIHSS.
Measured: 0-72 hours
Secondary outcomes (2)
Modified Rankin Scale
A good outcome is defined as a modified Rankin Scale (mRS) of ≤1 or return to baseline mRS.
Measured: 90 days
National Institutes of Health Stroke Scale (NIHSS)
An improvement of the NIHSS is defined as a 4-point improvement in the NIHSS, or NIHSS 0 measured 24 hours after treatment.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startAug 2011
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Scripps Health
- Responsible party
- Principal investigator, Thomas M Hemmen, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150266
- Sponsor's protocol ID
- AWOKE
- Other IDs
- 5P50NS044148
- Acronym
- AWOKE
- Status last verified
- Sep 2013
- First submitted
- 23 Jun 2010
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteplase for Waking Onset STROKE
- ClinicalTrials.gov ID
- NCT01150266
- Acronym / sponsor ID
- AWOKE / AWOKE
- Conditions
- Ischemic Stroke
- Keywords
- stroke, ischemia, thrombolysis, thrombolytics, tPA, rt-PA, t-PA, Activase®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Scripps Health
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- First posted
- 24 Jun 2010 (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.
This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present with stroke symptoms upon awakening.
Detailed description
Patients with ischemic stroke are currently only eligible for the treatment with intravenous thrombolysis if the stroke is diagnosed within 4.5 hours from known onset of symptoms.
Many patients awaken with stroke and are excluded from this therapy, following current guidelines.
Patients who suffer from a stroke just before or after waking up may be candidates for thrombolysis and our study will use advanced neuroimaging to select those patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alteplase | Experimental | Drug: Alteplase (tPA)Alteplase 0.9mg/kg (maximum 90mg), 10% IV bolus over 1 minute and the remainder over one hour infusion in patients with ischemic stroke after awaking. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥22
- Stroke upon awakening
- Measurable deficit by NIHSS
- No deficit before sleep or last seen normal before to sleep
- Head CT with no evidence of intracranial hemorrhage.
Key exclusion criteria (16 listed)
- Stroke or serious head trauma within the preceding 3 months
- Major surgery or serious trauma within 14 days
- History of intracranial hemorrhage
- Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures.
- Rapidly improving or minor symptoms
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 |
|---|---|---|
| Alteplase (tPA)Also: Activase®, rt-PA, t-PA, tPA0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour. | Drug | Alteplase |
Primary outcome
Symptomatic Intracranial Hemorrhage
Time frame: 0-72 hours
sICH is defined as any confluent dense hematoma occupying greater than 30% of the infarcted area with substantial space occupying effect, or any brain hemorrhage outside the infarcted area that occurs within 72 hours of tPA treatment and is associated with an increase of at least 4 points in the NIHSS.
2 secondary outcomes
Modified Rankin Scale
Time frame: 90 days
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- UCSD Stroke CenterLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alteplase (tPA) in people with Ischemic Stroke, run by University of California, San Diego 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 9 inclusion and 16 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: withdrawn, as of the sponsor's last update on 13 Sep 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Symptomatic Intracranial Hemorrhage (time frame: 0-72 hours). 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 13 Sep 2013.