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.
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 study will involve screening approximately 7000 patients at 60-70 investigational centers in the US and Canada, and enrollment is expected to be complete in 2009.
Steven Frankel, CEO of Accumetrics, said: “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.”