Navigation Links
Accumetrics Announces the Launch and First Patient Enrolled Into the GRAVITAS Trial
Date:6/16/2008

SAN DIEGO, June 16 /PRNewswire/ -- Patient enrollment into the GRAVITAS (Gauging Responsiveness With A VerifyNow(R) Assay-Impact On Thrombosis And Safety) trial has begun, officials from Accumetrics announced today. The GRAVITAS trial is designed to evaluate the use of the VerifyNow P2Y12 test to identify patients that exhibit a low response to antiplatelet therapy who are at risk for adverse cardiac events, and prove that these at-risk patients will benefit from tailored antiplatelet therapy.

Various studies have shown that there is variability in how patients respond to antiplatelet therapy, and that up to 30% are non-responsive to antiplatelet medication, such as clopidogrel (Plavix(R)). These patients have a high degree of platelet reactivity and, as a result, are at greater risk of a major adverse cardiac event (MACE), such as cardiovascular death, myocardial infarction or stent thrombosis. With other medications such as statins, insulin and anticoagulants, patients benefit from individually tailored dosing to adequately manage their condition. The GRAVITAS trial will be the first trial conducted to demonstrate that patient outcomes are improved when dosing is tailored to the patient's response to clopidogrel as determined using the VerifyNow P2Y12 test.

The GRAVITAS trial is a double-blind, placebo-controlled, randomized trial that employs the VerifyNow P2Y12 test to classify patients undergoing percutaneous coronary intervention receiving a drug-eluting stent as "responsive" or "non-responsive" to clopidogrel. The trial's primary purpose is to evaluate whether patients (identified as non-responders) that are randomized to a tailored treatment have fewer adverse cardiac events than non-responders randomized to receive standard therapy. The study will involve screening approximately 7000 patients at 60-70 investigational centers in the United States and Canada, and enrollment is expected to be complete in 2009.

Matthew J. Price, MD, Director of the Cardiac Catheterization Laboratory at Scripps Clinic in La Jolla, California is the Principal Investigator for the trial. The Executive Committee comprises a group of nationally recognized physicians in the field of cardiology and includes Dr. Price, Eric Topol, MD, Paul Teirstein, MD, Peter Berger, MD, and Christopher Cannon, MD.

"The GRAVITAS trial, using the VerifyNow P2Y12 test to gauge patients' response, is prototypic of the future of individualized medicine," said Dr. Price. "Not everyone responds the same way to current antiplatelet medications, so why should we treat our patients as if they did? The results of this trial will help physicians make clinical decisions to maximize safety and improve outcomes for a large number of patients taking anti-platelet therapy."

"We are very excited that patient enrollment into the GRAVITAS trial has commenced, and we are fortunate to be working with many of the nation's leading experts in cardiology," said Steven Frankel, Accumetrics CEO. "We believe that the results from GRAVITAS will provide a more thorough understanding of how patients respond to their antiplatelet therapy, and further substantiate that individualized therapy is more effective than a one-size-fits-all approach."

About the VerifyNow P2Y12 Test:

The VerifyNow P2Y12 test is a whole blood point-of-care assay that is used to measure the level of P2Y12 receptor blockade. The GRAVITAS trial is being conducted under an Investigational Device Exemption from the U.S. FDA.

About Accumetrics (http://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.

VerifyNow is the first simple and rapid system for measuring the individual response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, Plavix(R), ReoPro(R), and Integrilin(R), the VerifyNow system provides a valuable tool to help guide treatment decisions.

CONTACT: Steven Frankel, 858-404-8201, sfrankel@accumetrics.com.

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.


'/>"/>
SOURCE Accumetrics
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Accumetrics Announces $28.8 Million Financing and Initiation of Pivotal Clinical Trial
2. ADVENTRX Announces CoFactor(R) Phase 2b Clinical Trial Overall Survival Results
3. Disc Motion Technologies Announces First Human Implants of True TSMS(TM) Device
4. Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung Infections
5. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
6. Vion Pharmaceuticals Announces Presentation of Data of Cloretazine(R) (VNP40101M) in Elderly Patients with High-Risk Myelodysplastic Syndromes at the EHA Annual Meeting
7. XTENT Announces European Regulatory Update
8. PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
9. Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
10. Cardiogenesis Announces Preliminary Clinical Results With the PHOENIX System Combining TMR + Stem Cells
11. Targeted Genetics Announces Positive Phase 1/2 tgAAC94 Data Presented at Annual European Congress of Rheumatology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... -- CSI Specialty Group (CSI) expanded its specialty pharmacy ... Pharmacy Podcast. A free, weekly show, the Specialty Pharmacy ... discussion and context amongst specialty pharmacy peers and professionals. ... The Specialty Pharmacy Podcast, hosted by industry leader ... DiMascio, CHE, CMCE, CPC, is available for streaming and/or ...
(Date:2/10/2016)... and SAN DIEGO , Feb. 10, ... global leader in viral gene therapy manufacturing, and Renova™ ... congestive heart failure and other chronic diseases, have entered ... manufacturing process and produce cGMP-grade RT-100 (Ad5.hAC6) Drug Product ... --> --> This relationship ...
(Date:2/10/2016)... -- Urologix, the market leader for in-office minimally invasive ... (BPH), announces new private ownership and is operating as ... industry veteran of more than 20 years, has been ... Plymouth, Minn. The company,s two ... RF Therapy, will continue to be broadly available and ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... As part of its ongoing series of ... Each webinar features a dynamic expert and thoughtful presentation to give attendees a ... facilities. Both events are free to attend, but registration is required. ...
(Date:2/10/2016)... ... February 10, 2016 , ... Emergency rooms provide emergency care to stabilize ... can leave patients with dental emergencies at risk of losing a tooth or their ... care. , Common dental emergencies include:, , Avulsed or ...
(Date:2/10/2016)... ... February 10, 2016 , ... Intalere’s 2016 Executive ... than 200 of the country’s top healthcare executives to share insights on transformational ... of the Forum is the provider-centric perspective, experience, expertise and strategy shared by ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... award winner and inspirational speaker Jan Fox will serve as keynote speaker at ... will provide participants with tools to more effectively communicate with their own organizational ...
(Date:2/10/2016)... ... February 10, 2016 , ... Everseat has joined ... readily available to physicians. The integration will enable Allscripts users to post open ... Everseat’s free mobile app. , The partnership gives Everseat substantial added power to ...
Breaking Medicine News(10 mins):