Status:
WITHDRAWN
Study for the Use of Alteplase in Patients Who Awaken With Stroke
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Scripps Health
Conditions:
Ischemic Stroke
Eligibility:
All Genders
22+ years
Phase:
PHASE1
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 awake...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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.
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01150266
Start Date
August 1 2011
Last Update
September 13 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Diego
San Diego, California, United States, 92037-0979