Accumetrics, Inc. Announces Completion of GRAVITAS Trial EnrollmentBy Accumetrics Inc., PRNE
Monday, April 5, 2010
SAN DIEGO, April 6, 2010 - Accumetrics, Inc., a privately-held developer and marketer of the
VerifyNow(R) 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(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 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."
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(R)) and clopidogrel (Plavix)), and GP IIb/IIIa inhibitors (e.g.
ReoPro(R) and Integrilin(R)), 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 +1-212-838-3777 firstname.lastname@example.org Timothy I. Still President and CEO Accumetrics +1-858-404-8260 email@example.com
Megan Rusnack of Lippert/Heilshorn & Associates, +1-212-838-3777, mrusnack at lhai.com; or Timothy I. Still, President and CEO of Accumetrics, +1-858-404-8260, press at accumetrics.com
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