Study for the Use of Alteplase in Patients Who Awaken With Stroke (AWOKE)
This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present with stroke symptoms upon awakening.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Alteplase for Waking Onset STROKE|
- Symptomatic Intracranial Hemorrhage [ Time Frame: 0-72 hours ] [ Designated as safety issue: Yes ]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.
- Modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]An improvement of the NIHSS is defined as a 4-point improvement in the NIHSS, or NIHSS 0 measured 24 hours after treatment.
|Study Start Date:||August 2011|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
Drug: Alteplase (tPA)
0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
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.
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92037-0979|