SAN DIEGO, CA, — Patient enrollment into the GRAVITAS (Gauging Responsiveness With A VerifyNow® 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, Director of the Cardiac Catheterization Laboratory at Scripps Clinic in La Jolla, California is the Principal Investigator for the trial. The Executive Committee comprises a group of nationally recognized physicians 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 antiplatelet medications, so why should we treat our patients as if they did? The results of this trial will help physicians make clinical decisions to maximize safety and improve outcomes for a large number of patients taking anti-platelet therapy.”
“We are very excited that patient enrollment into the GRAVITAS trial has commenced, and we are fortunate to be working with many of the nation’s leading experts in cardiology,” said Steven Frankel, Accumetrics CEO. “We believe that the results from GRAVITAS will provide a more thorough understanding of how patients respond to their antiplatelet therapy, and further substantiate that individualized therapy is more effective than a one-size-fits-all approach.”
About the VerifyNow P2Y12 Test:
The VerifyNow P2Y12 test is a whole blood point-of-care assay that is used to measure the level of P2Y12 receptor blockade. The GRAVITAS trial is being conducted under an Investigational Device Exemption from the U.S. FDA.
About Accumetrics (http://www.accumetrics.com)/
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.
VerifyNow is the first simple and rapid system for measuring the individual response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, Plavix(R), ReoPro(R), and Integrilin(R), the VerifyNow system provides a valuable tool to help guide treatment decisions.
Steven Frankel, 858-404-8201, sfrankel.
Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc., ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of Sanofi-Aventis.