3K3A-APC & tPA in Acute Hemispheric Ischemic Stroke
Key Inclusion Criteria
- Age 18 to 80 years, inclusive
- Acute ischemic stroke, secondary to presumed blockage of blood vessel
- Able to receive intravenous tissue plasminogen activator within three hours of stroke onset
- National Institutes of Health Stroke Scale score of seven to 20
Key Exclusion Criteria
- History of stroke or penetrating head injury within 90 days
- Use of oral anticoagulants within 48 hours prior to enrollment
- History of previous or current diagnosis of intracranial hemorrhage
- Weight greater than 129 kilograms
- Pregnant or breastfeeding
Full Study Name
A Multicenter, Phase II Study Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC, a Recombinant Variant of Human Activated Protein C (APC) in Combination with Tissue Plasminogen Activator (tPA) in Moderately Severe Acute Hemispheric Ischemic Stroke (RHAPSODY) (IRB no. 36025)
The purpose of this study is to determine whether the investigational drug 3K3A-APC is safe at various dose levels in patients who have had a stroke and who have also received the “clot buster” drug tPA. 3K3A-APC may protect the brain after a stroke by keeping brain cells alive and by reducing inflammation.
Participants will be assigned to receive either 3K3A-APC or placebo. Researchers will test four dose levels of 3K3A-APC, which will be given intravenously.