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Atrial
Fibrillation, a heart rhythm disorder in which
the heart's upper two chambers quiver rather than
effectively pump blood throughout the body, affects
up to 2.2 million Americans, according to the
American Heart Association. One of the potentially
deadly side effects of this ineffective pumping
is that blood can pool and clot. A blood clot
that is pumped out of the heart can result in
a life-threatening stroke. In fact, 15 percent
of strokes occur in patients with atrial fibrillation.
A team of Huntington
Hospital experts is participating in a global
clinical trial to study the ability of a new anticoagulant
- a medication that reduces blood clotting - to
prevent strokes in high risk atrial fibrillation
patients.
Currently, the drug
of choice in preventing strokes is warfarin, marketed
as Coumadin.
"Warfarin is one of
the most disliked medicines by both patients and
doctors," said Paul Maccaro, MD, Director of Electrophysiology
at Huntington and Principal Investigator of the
current study. Dr. Maccaro explained that warfarin,
administered just once a day, is difficult to
regulate. "Patients must have their blood routinely
monitored to ensure that the drug is maintained
at a safe level."
To help regulate warfarin
levels in the blood, patients taking the medication
are subjected to a range of lifestyle restrictions.
"It interacts with
food and many medications, including antibiotics,
birth control pills, and herbals," Dr. Maccaro
noted. "Patients on warfarin always need to worry
about what they are doing, taking and eating."
The goal of this study,
dubbed Aristotle, is to determine if a newly developed
medication called apixabin will be as effective
as warfarin in preventing stroke in atrial fibrillation
patients. It has already undergone clinical trials
in Europe and has been shown to have fewer side
effects and to be better tolerated by patients.
 "The
dose of apixabin is weight and agebased, so it
is easier to regulate," Dr. Maccaro noted. "We're
hoping to identify a drug that will be more convenient
for patients, doctors and nurses."
The study is double-blinded,
explained site study coordinator Dana Kuziw, RN.
This means that, in an effort to make sure that
the data is free from bias, neither hospital staff
nor the patient will know which medication the
patient is taking.
The scope and structure
of the Aristotle study are somewhat unique. Its
sponsors, Bristol-Myers Squibb and Pfizer, have
designed a large-scale, multinational project.
"As of December, there
were 900 participating sites in 39 countries,"
reported Ms. Kuziw. "The study sponsor is anticipating
that they will enroll a total of 15,000 patients."
Yet, according to Dr.
Maccaro, there is no firm time or enrollment limit
on the study. "Often at the end of a largescale
study, investigators review the data and come
to the conclusion that further study is needed,"
Dr. Maccaro observed. "Aristotle has been structured
so that the study will continue until a threshold
number of adverse events have been recorded."
This will guarantee
that researchers have gathered enough data to
make a determination about whether apixabin is
at least as safe as warfarin.
Eligible patients will
be those with atrial fibrillation who are classified
as being at high risk for a stroke.
Among the advantages
of participating in this or any clinical research
study are free medications, free diagnostic examinations,
and free physical exams. Another well documented
although less tangible benefit is the reassurance
that results from being under close surveillance.
"One of the benefits
of being a research subject is that outcomes are
better whether patients are receiving the study
medication, the placebo or are in the control
group," Dr. Maccaro pointed out. "Part of the
nature of participating in a study is that you
receive more teaching, greater surveillance, and
more rigorous follow up."
Dr. Maccaro and Ms.
Kuziw are working on this project with sub-investigators
Kent Stephenson, MD, electrophysiologist, and
Carol Patrick, ACNP. For additional information,
or to find out if you are eligible to participate,
please call the electrophysiology department at
(631) 351-2798. //
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