The study, to be led by Joseph Broderick,
MD, chair of UC's neurology department, and Thomas Tomsick, MD,
director of neuroradiology, will be the first randomized trial of its
type in acute ischemic stroke.
It will also be the first to compare new
procedures against the standard approach to clear clogged brain
arteries, the cause of ischemic stroke.
Opening clogged arteries in stroke
patients quickly is important, because the longer the blood supply to
the brain is blocked, the more likely long-lasting brain damage will
Known as the Interventional Management of
Stroke (IMS) III Trial, the study will compare results in about 900
U.S. and Canadian stroke patients treated either with the widely used
intravenous, clot-busting drug tissue plasminogen activator (tPA), or
with a combination of approaches.
Study participants will be randomized to
receive either standard doses of tPA, a reduced tPA dose delivered to
the clogged brain artery through a catheter that uses ultrasound to
break up clots, or a reduced tPA dose and removal of the clot using a
mechanical device called a Merci Retriever.
"Cardiologists have used combinations of
drugs and devices to unblock heart arteries for several years. We hope
that this trial can be the first step in that direction for acute
stroke," says Dr. Broderick.
"We're hoping this will lead to a
paradigm shift in stroke treatment, from the standard tPA dose given
intravenously to less tPA and a more interventional approach, which
will be whatever is needed to open the artery," adds Dr. Broderick.
"This will mean that instead of just
using an IV, centers that have the expertise will be able to do a more
complete job. I think this will be the next major step in stroke
treatment, but we must test it thoroughly to ensure it's appropriate."
Pilot studies at U.S. and Canadian
centers found that the combined approach was encouraging enough
compared with the standard tPA treatment to merit this new Phase III
investigation, which will be conducted at 50 centers in the United
States and Canada, including 11 hospitals in the Greater
Cincinnati/Northern Kentucky area.