SAN DIEGO, June 30 /PRNewswire/ -- Accumetrics, Inc. announces that it has reached the halfway mark (1,600 patients) in the enrollment of 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.
"We are thrilled to have reached the halfway point for enrollment in our GRAVITAS trial," said Jeff Dahlen, Ph.D, Vice President, Clinical and Regulatory Affairs of Accumetrics, Inc. "Once complete, GRAVITAS will be the largest multi-center clinical trial that links testing with personalized medicine and improved patient outcomes. We continue our commitment to ensuring that the VerifyNow System is shown to be an integral tool in optimizing the use of antiplatelet therapy."
The concept of variability in response to antiplatelet therapy has been well established. Also being demonstrated with increased frequency is the question of whether poor response to antiplatelet therapy, based on a laboratory test, leads to poor patient outcomes. 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 and P2Y12 Test reduces major cardiovascular adverse events post-PCI. The trial is being coordinated by Scripps Advanced Clinical Trials.
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 EC-cleared product for prasugrel and 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., ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis.
CONTACT: Jules Abraham Lippert/Heilshorn & Associates 212-838-3777 firstname.lastname@example.org Timothy I. Still President and CEO Accumetrics 858-404-8260 email@example.com
|SOURCE Accumetrics, Inc.|
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