Sexual HealthAccumetrics, Inc. Announces 1000th Patient Enrolled In GRAVITAS Trial
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."
About GRAVITAS
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.
Accumetrics, Inc.