The written-up article here:
Eptifibatide plus tPA looks promising for ischemic stroke
The clincal writeup here:
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-ER)
Detailed Description:
The
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute
Ischemic Stroke-Enhanced Regimen (CLEAR-ER Stroke) trial is a Phase II
trial and part of the Specialized Program on Translational Research in
Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance
delivery of acute stroke patient care and train acute stroke
translational researchers.
Stroke most often occurs
when blood flow to the brain stops because it is blocked by a blood
clot. When a blood clot blocks the blood supply to the brain, parts of
the brain may not get enough blood and oxygen to survive. As a result,
permanent brain damage can occur, which can affect a person's ability to
walk, talk, and function independently. In order to reduce the risk of
permanent damage, it is important to restore blood flow to the brain as
quickly as possible.
rt-PA, used alone, is
already approved by the Food and Drug Administration (FDA) as treatment
for patients with a stroke caused by blockage of an artery in the brain
and when given within 3 hours of the onset of stroke symptoms.
Eptifibatide is also already FDA-approved as a treatment for blood clots
causing heart attack. The investigational aspect of this study is the
use of eptifibatide for a stroke victim in combination with rt-PA.
The CLEAR Stroke Trial
demonstrated that the combination of low dose rt-PA plus eptifibatide
can be safely given to acute ischemic stroke patients within 3 hours of
symptom onset.
The CLEAR-ER Stroke Trial
is designed to provide data concerning the risks and benefits of
combining eptifibatide with medium dose intravenous rt-PA in 126 acute
ischemic stroke patients within 3 hours of symptom onset. Patients will
be randomized to a combined intravenous medium-dose rt-PA and
eptifibatide regimen, or standard dose rt-PA in a 5 to 1 ratio. This
will result in a total of 105 patients treated with a combined regimen,
and 21 patients treated with standard dose IV rt-PA alone.
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