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Study of genomics of antiplatelet therapy continues

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The TAILOR-PCI study has received an additional $7 million from the National Heart, Lung and Blood Institute to complete research on whether prescribing antiplatelet therapy based on a patient’s CYP2C19 genotype will prevent MI, stroke, unstable angina and CV death in patients who undergo PCI.

TAILOR-PCI, which began in 2013, currently has 29 participating centers, with plans to add more. Target enrollment is 5,270 participants. The randomized comparison of clopidogrel (Plavix, Sanofi-Aventis/Bristol-Myers Squibb) and ticagrelor (Brilinta, AstraZeneca) was launched by the Mayo Clinic Center for Individualized Medicine and the Mayo Clinic department of cardiovascular diseases, in collaboration with Peter Munk Cardiac Centre, University Health Network, Toronto, and Spartan Bioscience, Ottawa.

This is “a true multinational collaboration designed to best inform clinical practice,” principal investigator Michael Farkouh, MD, MSc, cardiologist at Peter Munk Cardiac Centre, University Health Network, said in the release.

The purpose of the study is to determine if genetic testing can identify the best antiplatelet therapy, for patients who undergo a coronary stent placement and do not activate clopidogrel well. The primary outcome measure is the occurrence of MACE, including nonfatal MI, nonfatal stroke, CV mortality, severe recurrent ischemic and stent thrombosis, according to the study description on ClinicalTrials.gov.

“The NHLBI grant is validation of the importance of the question that needs to be answered: Is pharmacogenomics useful in prescribing individualized antiplatelet therapy after PCI,” Naveen Pereira, MD, cardiologist at Mayo Clinic and principal investigator of TAILOR-PCI, said in the release. “This study will tell us whether this gene plays an important role in determining response to antiplatelet therapy after coronary interventions.”

The randomized, parallel-assignment, open-label study has an estimated study completion date of March 2020, according to ClinicalTrials.gov.

“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, chief of the atherothrombosis and coronary artery disease branch of NHLBI, said in the 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.”

For more information:

Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI). clinicaltrials.gov/ct2/show/NCT01742117.

Disclosure: Cardiology Today’s Intervention could not confirm relevant financial disclosures.