Jefferson Stroke Center Explores New Drug Therapies
Research to improve the clinical outcomes of stroke victims
is under way at the Jefferson Stroke Center at Thomas Jefferson University
Hospital. The effects of three drugs - alteplase, also known as tissue
plasminogen activator (t-PA); citicoline; and lubeluzole are being studied
in separate clinical trials.
Will t-PA be effective three to five hours after onset of symptoms?
The U.S. Food and Drug Administration (FDA) recently approved the use of
t-PA (a genetically engineered clot-dissolving agent) within the first three
hours after the onset of acute ischemic stroke, a rapidly occurring stroke
caused when a blood clot blocks or "plugs" a blood vessel in the
brain. Now, researchers at Jefferson are exploring its use within the first
three to five hours after the onset of symptoms.
"Although t-PA is an advancement in stroke treatment, many patients
do not arrive at the hospital emergency room in enough time to be treated,"
explains Rodney Bell, MD, director of the Stroke Center. "It is hoped
that this extra time will give patients the opportunity to seek the emergent
care they need."
Jefferson's study will compare the effects of t-PA, which has been successful
in the management of acute heart attack and acute massive pulmonary embolism,
against a placebo in acute ischemic stroke patients unable to be treated
within three hours of the start of stroke symptoms, but before five hours.
The chances of a patient being given t-PA in this study are 50 percent.
Eligibility requirements include a history of past medical conditions, having
a blood test evaluation, completing performance tests to assess the degree
of stroke and having a CT scan. Medical examinations will be repeated several
times over three months.
Will citicoline, reduce blockage and promote membrane repair?
The drug citicoline is being investigated as a possible neuroprotector (cell
preserving agent) that may prevent ongoing damage after the onset of acute
ischemic stroke. Patients participating in this double-blind study must
receive the drug orally within 24 hours after onset of stroke symptoms.
Citicoline may reduce the size of the blockage in addition to promoting
membrane repair and significant improvements in motor function. Patients
will receive citicoline versus a placebo over a six-week treatment period
with a six-week follow-up.
Eligible criteria include a CT scan to rule out brain tumor or hemorrhage
are those with terminal systemic disease and certain cardiovascular conditions
Does lubeluzole improve neurological and functional recovery?
Jefferson is also one of a few select medical centers participating in an
international study of a new investigational drug called lubeluzole, which
also is a neuroprotector. The study will determine if the new treatment
will improve neurological and functional recovery if administered within
eight hours of stroke onset. Participation requires hospitalization for
five days and a 12-week observation period, including a patient analysis
at four and 12 weeks.
Each year, an estimated 550,000 people suffer a new or recurrent stroke,
making it the number one cause of disability and the third leading cause
of death in the United States. The majority of strokes are ischemic which
deprive brain cells of oxygen. Unfortunately, statistics show that many
people wait too long before seeking medical attention, resulting in irreparable
"We need to begin to recognize that stroke must be treated as an emergency,
just as we managed heart attacks," concludes Dr. Bell. "Patients
should immediately go to a hospital emergency room. Time is critical following
a stroke, as it affects the ability of damaged brain cells to recover."