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Accumetrics Announces the Launch and First Patient Enrolled Into the GRAVITAS Trial
Date:6/16/2008

SAN DIEGO, June 16 /PRNewswire/ -- Patient enrollment into the GRAVITAS (Gauging Responsiveness With A VerifyNow(R) Assay-Impact On Thrombosis And Safety) trial has begun, officials from Accumetrics announced today. The GRAVITAS trial is designed to evaluate the use of the VerifyNow P2Y12 test to identify patients that exhibit a low response to antiplatelet therapy who are at risk for adverse cardiac events, and prove that these at-risk patients will benefit from tailored antiplatelet therapy.

Various studies have shown that there is variability in how patients respond to antiplatelet therapy, and that up to 30% are non-responsive to antiplatelet medication, such as clopidogrel (Plavix(R)). These patients have a high degree of platelet reactivity and, as a result, are at greater risk of a major adverse cardiac event (MACE), such as cardiovascular death, myocardial infarction or stent thrombosis. With other medications such as statins, insulin and anticoagulants, patients benefit from individually tailored dosing to adequately manage their condition. The GRAVITAS trial will be the first trial conducted to demonstrate that patient outcomes are improved when dosing is tailored to the patient's response to clopidogrel as determined using the VerifyNow P2Y12 test.

The GRAVITAS trial is a double-blind, placebo-controlled, randomized trial that employs the VerifyNow P2Y12 test to classify patients undergoing percutaneous coronary intervention receiving a drug-eluting stent as "responsive" or "non-responsive" to clopidogrel. The trial's primary purpose is to evaluate whether patients (identified as non-responders) that are randomized to a tailored treatment have fewer adverse cardiac events than non-responders randomized to receive standard therapy. The study will involve screening approximately 7000 patients at 60-70 investigational centers in the United States and Canada, and enrollment is expected to be complete in 2009.

Matthew J. Price, MD,
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SOURCE Accumetrics
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