Study of PCI patients to examine genotype-based medication choices
A trial is underway to investigate whether antiplatelet therapy prescription based on a patient’s CYP2C19 genotype affects outcomes in patients undergoing PCI, according to an announcement from the Mayo Clinic.
Investigators for the randomized, open-label Tailored Antiplatelet Therapy to Lessen Outcomes after Percutaneous Coronary Intervention (TAILOR-PCI) study plan to enroll approximately 5,300 patients at five Mayo Clinic locations and 10 other sites in the United States, Canada and South Korea, according to a press release.
The standard of care is to prescribe clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) to patients undergoing PCI, but some patients have a variation in the CYP2C19 gene that may reduce ability to activate clopidogrel, Naveen Pereira, MD, a Mayo Clinic cardiologist and principal investigator of TAILOR-PCI, stated in the release.
“What we don’t know — and why there is such confusion in the cardiovascular community — is how these genetic changes affect long-term clinical outcomes and whether we can decrease overall health care costs,” Pereira said.
According to information from the TAILOR-PCI page at clinicaltrials.gov, patients will have genetic samples taken at baseline and will be randomly assigned into three groups:
- Patients who will have their DNA samples frozen for 12 months. During that time, they will be prescribed 75 mg/day clopidogrel. At 12 months, their DNA will be tested to determine whether they have the variation in the CYP2C19 gene.
- Patients who will be prescribed 75 mg/day clopidogrel for 12 months because their baseline DNA test shows they do not have the variation in the CYP2C19 gene.
- Patients who will be prescribed 90 mg ticagrelor (Brilinta, AstraZeneca) twice daily for 12 months because their baseline DNA test shows they have the variation in the CYP2C19 gene. Ticagrelor is not activated by the CYP2C19 pathway.
The primary outcome is MACE — defined as nonfatal MI, nonfatal stroke, CV death, severe recurrent ischemia or stent thrombosis — at 12 months. The secondary outcome is the number of patients with the variation in the CYP2C19 gene who have major or minor bleeding at 12 months.
“Ultimately, what we’re trying to do with TAILOR is use pharmacogenomics to determine whether choosing medication based on an individual genotype will help patients live longer and whether the benefits will outweigh the risks of alternative therapies,” Pereira stated in the release.
All DNA samples collected will become part of a CAD biobank available to any researchers, according to the press release.
The study is expected to be completed in 2016.