Apr 7 2010
Accumetrics, Inc., a privately-held developer and marketer of the VerifyNow® System, the first rapid and easy to use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced that it has completed the enrollment phase of its landmark clinical trial, GRAVITAS (Gauging Responsiveness with A VerifyNow® Assay Impact on Thrombosis And Safety). The trial is specifically designed to demonstrate the value of providing clinicians with actionable information for patients who are poor responders to clopidogrel (Plavix®). The multi-center, placebo controlled trial will determine whether tailored antiplatelet therapy for poor responders, identified based on the results of the company's VerifyNow P2Y12 Test, reduces major adverse cardiovascular events (e.g., heart attack, stent thrombosis) following percutaneous coronary intervention (PCI). The trial is being conducted at approximately 80 sites in the U.S. and Canada, and has enrolled approximately 2,800 patients.
"We are thrilled to have concluded the enrollment phase of the GRAVITAS trial," said Jeff Dahlen, Ph.D., Vice President, Clinical and Regulatory Affairs of Accumetrics. "The recent increased attention on variability in patient response to clopidogrel has generated many questions. We believe GRAVITAS will provide critical answers about how to optimally manage these patients by personalizing the use of antiplatelet therapy."