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:6/23/2016)... 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) ... Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing ... With this clearance, Roche is the first IVD company ... for sepsis risk assessment and management. PCT ... PCT levels in blood can aid clinicians in assessing ...
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... -- The vast majority of dialysis patients currently receive ... usually 3 times a week, with treatment times averaging ... equipment preparation and wait time.  This regimen can be ... who are elderly and frail.  Many elderly dialysis patients ... for some duration of time. Residents in ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain ... for a minimum wage raise to $12 an hour by 2020 and then adjusting it ... the lost value of the minimum wage, assure the wage floor does not erode again, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions ... initiated cultivation and processing operations at its production facility, and opened its first ... is the manufacturer of a complete system of proactive air and surface purification ...
Breaking Medicine News(10 mins):