SAN DIEGO, June 16 Patient enrollment into the GRAVITAS(Gauging Responsiveness With A VerifyNow(R) Assay-Impact On Thrombosis AndSafety) trial has begun, officials from Accumetrics announced today. TheGRAVITAS trial is designed to evaluate the use of the VerifyNow P2Y12 test toidentify patients that exhibit a low response to antiplatelet therapy who areat risk for adverse cardiac events, and prove that these at-risk patients willbenefit from tailored antiplatelet therapy.
Various studies have shown that there is variability in how patientsrespond to antiplatelet therapy, and that up to 30% are non-responsive toantiplatelet medication, such as clopidogrel (Plavix(R)). These patients havea high degree of platelet reactivity and, as a result, are at greater risk ofa major adverse cardiac event (MACE), such as cardiovascular death, myocardialinfarction or stent thrombosis. With other medications such as statins,insulin and anticoagulants, patients benefit from individually tailored dosingto adequately manage their condition. The GRAVITAS trial will be the firsttrial conducted to demonstrate that patient outcomes are improved when dosingis tailored to the patient's response to clopidogrel as determined using theVerifyNow P2Y12 test.
The GRAVITAS trial is a double-blind, placebo-controlled, randomized trialthat employs the VerifyNow P2Y12 test to classify patients undergoingpercutaneous coronary intervention receiving a drug-eluting stent as"responsive" or "non-responsive" to clopidogrel. The trial's primary purposeis to evaluate whether patients (identified as non-responders) that arerandomized to a tailored treatment have fewer adverse cardiac events thannon-responders randomized to receive standard therapy. The study will involvescreening approximately 7000 patients at 60-70 investigational centers in theUnited States and Canada, and enrollment is expected to be complete in 2009.
Matthew J. Price, MD, Director of the Cardiac Catheterization Laboratoryat Scripps Clinic in La Jolla, California is the Principal Investigator forthe trial. The Executive Committee comprises a group of nationally recognizedphysicians in the field of cardiology and includes Dr. Price, Eric Topol, MD,Paul Teirstein, MD, Peter Berger, MD, and Christopher Cannon, MD.
"The GRAVITAS trial, using the VerifyNow P2Y12 test to gauge patients'response, is prototypic of the future of individualized medicine," said Dr.Price. "Not everyone responds the same way to current antiplateletmedications, so why should we treat our patients as if they did? The resultsof this trial will help physicians make clinical decisions to maximize safetyand improve outcomes for a large number of patients taking anti-platelettherapy."
"We are very excited that patient enrollment into the GRAVITAS trial hascommenced, and we are fortunate to be working with many of the nation'sleading experts in cardiology," said Steven Frankel, Accumetrics CEO. "Webelieve that the results from GRAVITAS will provide a more thoroughunderstanding of how patients respond to their antiplatelet therapy, andfurther substantiate that individualized therapy is more effective than aone-size-fits-all approach."
About the VerifyNow P2Y12 Test:
The VerifyNow P2Y12 test is a whole blood point-of-care assay that is usedto measure the level of P2Y12 receptor blockade. The GRAVITAS trial is beingconducted under an Investigational Device Exemption from the U.S. FDA.
About Accumetrics (http://www.accumetrics.com):
Accumetrics is committed to advancing medical understanding of plateletfunction and enhancing quality of care for patients receiving antiplatelettherapies by providing industry-leading and widely accessible diagnostic testsfor rapid platelet function assessment.
VerifyNow is the first simple and rapid system for measuring theindividual response to multiple anti