A Phase Ib/II in Patients With Acute Ischemic Stroke
Status:
Completed
Trial end date:
2018-07-09
Target enrollment:
Participant gender:
Summary
Stroke is the fifth leading cause of death in the United States and is the leading cause of
long term disability. Distinct geographic disparities in stroke mortality, with highest rates
in the southeast United States including Arkansas, are known as the "stroke belt." There the
average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the
leading cause of serious long-term disability. Between 2012 and 2030, disability and medical
costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with
the majority of the projected increase in costs arising from those 65 to 79 years of age.
There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in
85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion
of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue
plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood
vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it
reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond
the effective time window for therapy is a common reason for failure.
To reduce the devastating impact of stroke on individuals and society, the investigators
continue to seek ways to improve functional recovery and limit ischemic damage in stroke
patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has
recently shown strong positive effects in pre-clinical animal models of acute ischemic
stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants
and blood substitutes yet none have been successful.