SAN DIEGO, April 6 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.
Advertisement
"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."
Advertisement
About GRAVITAS
The concept of variability in response to antiplatelet therapy has been well established. Also being demonstrated with increased frequency is the relationship between poor response to antiplatelet therapy and poor patient outcomes. The GRAVITAS trial is the first multi-center, placebo-controlled study to determine whether tailored antiplatelet therapy, based on the results of Accumetrics' VerifyNow System and P2Y12 Test, reduces major adverse cardiovascular 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 to help physicians determine an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(®)) and clopidogrel (Plavix)), and GP IIb/IIIa inhibitors (e.g. ReoPro(®) and Integrilin(®)), the VerifyNow System provides a valuable tool to help physicians make informed treatment decisions.
The VerifyNow System is widely used in various clinical settings where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke. For more information about the Company and its products, visit www.accumetrics.com.
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. Effient is a registered trademark of Eli Lilly and Company.
CONTACT: Megan Rusnack Lippert/Heilshorn & Associates 212-838-3777 [email protected] Timothy I. Still President and CEO Accumetrics 858-404-8260 [email protected]
SOURCE Accumetrics, Inc.
