Alteplase for Waking Onset STROKE
Overview
- Phase
- Phase 1
- Intervention
- Alteplase (tPA)
- Conditions
- Ischemic Stroke
- Sponsor
- University of California, San Diego
- Locations
- 1
- Primary Endpoint
- Symptomatic Intracranial Hemorrhage
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
Investigators
Thomas M Hemmen
Director, UCSD Stroke Center
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Alteplase
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.
Intervention: Alteplase (tPA)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Modified Rankin Scale(90 days)
- National Institutes of Health Stroke Scale (NIHSS)(24 hours)