Clinical trial NCT01150266: Study for the Use of Alteplase in Patients Who Awaken With Stroke
Official title: Alteplase for Waking Onset STROKE
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Ischemic Stroke
Keywords: stroke
ischemia
thrombolysis
thrombolytics
tPA
rt-PA
t-PA
Activase®
Alteplase
wake-up stroke
waking onset stroke
sleep
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Scripps Health
First posted: 2010-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Symptomatic Intracranial Hemorrhage
timeFrame: 0-72 hours
Secondary outcomes:
measure: Modified Rankin Scale
timeFrame: 90 days
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References: