The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this trial is to determine if the drug 3K3A-APC is safe at different dose levels in people who have had a stroke and received treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy (clot removal with a device), or both.

Stroke is the leading cause of adult disability in America, and is one of the leading causes of death in the world.  If patients arrive at a hospital within 3 hours of their stroke beginning, thrombolytic therapy can be effective.  Recent clinical trials have shown that mechanical thrombectomy is also an effective treatment in a sub-set of patients. However, not all people respond to these therapies, therefore new effective treatments for stroke are needed.

This trial will test a new drug called 3K3A-APC—a recombinant variant of human activated protein C (APC)—that may protect the brain after a stroke by keeping brain cells alive and reducing inflammation.  The study will be coordinated by NeuroNEXT (the Network for Excellence in Neuroscience Clinical Trials) at about 15 sites around the U.S.

Approximately 100 eligible participants will be enrolled and randomly selected to receive either 3K3A-APC or a placebo (an inactive substance) every 12 hours for up to 5 doses.  Study researchers will be testing 4 different dose levels of 3K3A-APC.  Participants will be assigned to a specific dose level and will remain on that level for all 5 infusions.

Participants will receive daily in-hospital visits until discharged.  After hospital discharge, they will return to the study site for 4 out-patient visits.  Study staff also will follow-up with the participants via telephone calls.  Site visits may include outcome scales (measures used to evaluate the participants’ quality of care), physical examinations, magnetic resonance imaging (MRI), and blood draws.

Study duration for participants is about 90 days.

Eligibility Criteria:

  • Acute ischemic stroke
  • Able to receive IV tPA, mechanical thrombectomy, or both
  • National Institutes of Health Stroke Scale (NIHSS) score of ≥5

Note: This is not a complete eligibility criteria list.

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Location:

Multiple U.S. Locations