SAN DIEGO, May 13 /PRNewswire/ --
Accumetrics, Inc. announces that it has enrolled its 1,000th patient into its landmark clinical trial, GRAVITAS (Gauging Responsiveness with A VerifyNow(R) 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(R)). 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 cardiovascular adverse events (e.g., heart attack, stent thrombosis) following percutaneous coronary intervention (PCI). Currently the trial is being conducted at more than 70 sites in the U.S. and Canada, with a total enrollment goal of approximately 2,800 patients.
This is a very significant milestone for Accumetrics as it brings us ever-closer to our goal of demonstrating the value of the VerifyNow System. By identifying and adjusting therapy for patients that are not responding adequately to standard doses of clopidogrel, GRAVITAS will be the largest multi-center clinical trial that links testing with personalized medicine and improved outcomes. We believe that the VerifyNow System will be seen as an integral tool in ensuring that patients receive not only the most appropriate antiplatelet therapy, but also the adequate dose, said Jeff Dahlen, Ph.D, Vice President, Clinical and Regulatory Affairs of Accumetrics, Inc. We are very proud to reach this milestone, and look forward to completing enrollment soon, and sharing the results.
The concept of variability in response to antiplatelet therapy has been well established. The question of whether poor response to antiplatelet therapy, as measured by a laboratory test, leads to poor outcomes is also being demonstrated with increased frequency. However, Accumetrics recognizes the need for a study specifically designed to demonstrate the value of providing clinicians with actionable information to improve outcomes for those patients who are poor responders to antiplatelet therapy. As a result, the GRAVITAS study is the first multi-center, placebo-controlled study to determine whether tailored antiplatelet therapy based on the results of the company's VerifyNow System reduces major cardiovascular adverse events post-PCI.
About Accumetrics (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.
Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, Plavix, ReoPro(R), and Integrilin(R), the VerifyNow System provides a valuable tool to help physicians make informed treatment decisions.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc., Plavix is a registered trademark of Sanofi-Aventis, ReoPro is a registered trademark of Centocor, Inc., and Integrilin is a registered trademark of Millennium Pharmaceuticals.