NHLBI provides $7 million in funding for personalized medicine cardiovascular trial

Researchers from the Mayo Clinic in Rochester, Minnesota, and Toronto's Peter Munk Cardiac Center received $7 million in additional funding from the National Heart, Lung and Blood Institute (NHLBI) to support a randomized, personal medicine trial for patients undergoing coronary balloon angioplasty.

The TAILOR-PCI (Tailored Antiplatelet Therapy to Lessen Outcomes after Percutaneous Coronary Intervention) study began in 2013. As of late August, 29 medical centers in the U.S., Canada and South Korea have participated in the trial. The researchers plan on enrolling 5,270 patients and finish the study by March 2020.

During the study, patients undergoing PCI are randomized to receive 75 mg of clopidogrel (Plavix) once daily without prospective genotyping guidance or 75 mg of ticagrelor (Brilinta) once daily or 90 mg of ticagrelor twice daily with genotyping guidance.

The co-principal investigators are cardiologists Michael Farkouh, MD, of the Peter Munk Cardiac Center, and Naveen Pereira, MD, of the Mayo Clinic.

The study is examining if prescribing medications based on a patient’s CYP2C19 genotype will help prevent MI, stroke, unstable angina and cardiovascular death in patients undergoing PCI. The current standard of care in these patients is clopidogrel for one year.

Previous studies showed that patients with a CYP2C19 abnormality might not respond as well to clopidogrel. Patients in the TAILOR-PCI study have a blood sample drawn for DNA analysis, but the researchers perform genotyping using the samples only after patients take antiplatelet therapy for a year.

“NHLBI is happy to support this important study, which we hope will contribute to the evidence needed to start delivering precision medicine in clinical settings,” Yves Rosenberg, MD, MPH, NHLBI’s program officer for the study, said in a news release. “This trial could have global impact by potentially changing treatment recommendations for millions of individuals with coronary artery disease needing antiplatelet treatment after a percutaneous coronary intervention.”