TARGET-PCI trial to assess value of genetic & platelet function testing
A new clinical trial enrolling 1,500 patients will assess the efficacy of using genetic and platelet function tests to identify individual patient risk of developing a cardiac event after a coronary stenting procedure.
During the two-year TARGET-PCI (Thrombocyte Activity Reassessment and GenoTyping for PCI) trial, Paul A. Gurbel, MD, of the Sinai Center for Thrombosis Research in Baltimore, and colleagues will use the Verigene System point-of-care assay (Verigene IUO CBS Assay CYP219) to identify genotypes associated with the responsiveness of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis).
Patients in the control arm of the trial will be administered prasugrel (Effient, Eli Lilly/Daiichi Sankyo). Patients triaged to clopidogrel therapy based on genotyping and who have high platelet reactivity will be switched to prasugrel.
Primary endpoints will include cardiovascular death, non-fatal MI, stroke and the need for target vessel revascularization six months after PCI.
Gurbel et al will also use the VerifyNow P2Y12 assay to determine individual responses to antiplatelet reactivity.
The researchers will record platelet function at two weeks, and three and six months post-PCI.
The tests will evaluate the CYP219 gene which is carried by only 30 percent of the population and makes patients nonresponsive to treatment with clopidogrel. Since this discovery, the FDA has placed a black box warning on the drug stating that it may be less effective in patients who carry these specific genes.
“The FDA's black box warning has left clinicians in a conundrum since the pharmacogenetic testing that reveals a patients’ genetic profile is not readily available," said Gurbel. “This study will provide the missing piece to that puzzle by substantiating the importance of point-of-care genetic and platelet response testing in PCI patients. Our study will determine whether this type of testing can be administered and utilized in a relatively short amount of time to truly personalize antiplatelet therapy."
The Verigene System is classified as an investigational device that has not yet been approved or reviewed by FDA. The researchers estimate that the trial results will be available by late 2012.
During the two-year TARGET-PCI (Thrombocyte Activity Reassessment and GenoTyping for PCI) trial, Paul A. Gurbel, MD, of the Sinai Center for Thrombosis Research in Baltimore, and colleagues will use the Verigene System point-of-care assay (Verigene IUO CBS Assay CYP219) to identify genotypes associated with the responsiveness of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis).
Patients in the control arm of the trial will be administered prasugrel (Effient, Eli Lilly/Daiichi Sankyo). Patients triaged to clopidogrel therapy based on genotyping and who have high platelet reactivity will be switched to prasugrel.
Primary endpoints will include cardiovascular death, non-fatal MI, stroke and the need for target vessel revascularization six months after PCI.
Gurbel et al will also use the VerifyNow P2Y12 assay to determine individual responses to antiplatelet reactivity.
The researchers will record platelet function at two weeks, and three and six months post-PCI.
The tests will evaluate the CYP219 gene which is carried by only 30 percent of the population and makes patients nonresponsive to treatment with clopidogrel. Since this discovery, the FDA has placed a black box warning on the drug stating that it may be less effective in patients who carry these specific genes.
“The FDA's black box warning has left clinicians in a conundrum since the pharmacogenetic testing that reveals a patients’ genetic profile is not readily available," said Gurbel. “This study will provide the missing piece to that puzzle by substantiating the importance of point-of-care genetic and platelet response testing in PCI patients. Our study will determine whether this type of testing can be administered and utilized in a relatively short amount of time to truly personalize antiplatelet therapy."
The Verigene System is classified as an investigational device that has not yet been approved or reviewed by FDA. The researchers estimate that the trial results will be available by late 2012.