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)
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.
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
Please see complete list of inclusion and exclusion criteria.
Shlee Song, MD
Duy Le, MD
Patrick Lyden, MD
Mani Nezhad, MD
Konrad Schlick, MD
Study Coordinator and Contact:
Date Last Updated: