MedicalResearch.com Interview with:
Thomas J. Povsic, MD, PhD
Duke Clinical Research Institute
Duke University School of Medicine
Durham, North Carolina
MedicalResearch.com: What is the background for this study?
Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial.
As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing. This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban. All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator. Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization. Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did.