Ischemic Stroke
Conditions
Keywords
stroke, ischemia, thrombolysis, thrombolytics, tPA, rt-PA, t-PA, Activase®, Alteplase, wake-up stroke, waking onset stroke, sleep
Brief summary
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.
Interventions
DRUGAlteplase (tPA)
0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Scripps Health
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥22 2. Stroke upon awakening 3. Measurable deficit by NIHSS 4. No deficit before sleep or last seen normal before to sleep 5. Head CT with no evidence of intracranial hemorrhage. 6. Able to receive IV t-PA treatment within 2.5 hrs after patient awoke with deficit. 7. Written informed consent signed and dated by the patient (or patient's authorized representative) 8. Core lesion: ASPECTS ≥7 on MRI-DWI, CTP-CBV or CTA source imaging. 9. Mismatch of at least 20% measured by CT CVB/MMT or DWI/TTP
Exclusion criteria
1. Stroke or serious head trauma within the preceding 3 months 2. Major surgery or serious trauma within 14 days 3. History of intracranial hemorrhage 4. Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures. 5. Rapidly improving or minor symptoms 6. Symptoms suggestive of subarachnoid hemorrhage. 7. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days. 8. Arterial puncture at a non-compressible site within the previous 7 days 9. Seizure at the onset of stroke and considered the cause for the neurological symptom. 10. 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 11. 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. 12. Active internal bleeding 13. Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy). 14. Lumbar puncture within 7 days. 15. 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. 16. Unable to obtain CTA or perfusion brain studies (PWI or CTP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Intracranial Hemorrhage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | 90 days | A good outcome is defined as a modified Rankin Scale (mRS) of ≤1 or return to baseline mRS. |
| National Institutes of Health Stroke Scale (NIHSS) | 24 hours | An improvement of the NIHSS is defined as a 4-point improvement in the NIHSS, or NIHSS 0 measured 24 hours after treatment. |
Countries
United States
Outcome results
None listed