3K3A-APC and tPA in Moderately Severe Acute Hemispheric Ischemic Stroke (RHAPSODY)

Condition/Intervention:

  • Stroke

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)

Phase:

Phase 2

Summary:

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.

Principal Investigator:

Shlee Song, MD

Co-Investigators:

Duy Le, MD
Patrick Lyden, MD
Mani Nezhad, MD
Konrad Schlick, MD

Study Coordinator and Contact:

Pooja Khanolkar
Phone: 310-967-8358
Email: pooja.khanolkar@cshs.org

Status:

Active

IRB No.:

36025

Date Last Updated:

05/15