This is a randomized, prospective, open label study to determine the cost-effectiveness of genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI) with stent implantation, will be randomized either to genotype guided dosing of antiplatelet therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.
Name: CYP2C19 genotypingDescription: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround timeType: Genetic
CYP2C19 Genotype guided
Description: The number (percentage) of participants receiving prasugrel/ticagrelor in each randomized armMeasure: The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor Time: for up to 7 days after PCI
Description: Agreement to suggested treatment recommendations based on genotype. The agreement rate was defined as the number of participants in genotyped group with loss of function variants that received prasugrel or ticagrelor + the number of participants without these variants that received clopidogrel divided by the total number in this group.Measure: Number of Participants With Drug Orders in Agreement With the Genotype-guided Recommendations Time: for up to 7 days after PCI
Description: major cardiac events defined as occurrence of first myocardial infarction, ischemic stroke, cardiovascular death, stent thrombosis, or need for urgent revascularizationMeasure: Number of Participants With Major Cardiac Events Time: 1 year
Description: major bleeding events defined by the Bleeding Academic Research Consortium (BARC) type 3 or 5. Type 3= Overt bleeding requiring: blood transfusion, surgical intervention or intravenous vasoactive agents; cardiac tamponade; intracranial hemorrhage; intraocular bleeding. Type 5= fatal bleedingMeasure: Number of Participants With Bleeding Events Time: 1 year
There is one SNP
The most common loss of function (LOF) allele is *2 (c.681G>A; rs4244285), with frequencies of ~15% in Caucasians and Africans and 29-35% in Asians.