Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI)
Coronary Artery Disease, Acute Coronary Syndrome, Stenosis

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring percutaneous coronary intervention, angioplasty
Eligibility Criteria
Inclusion
- Patient >18 years of age
- Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (CAD)
- Patient is eligible for PCI
- Patient is willing and able to provide informed written consent
5.3 Exclusion
- Patient not able to receive 12 months of dual anti-platelet therapy
- Failure of index PCI
- Patient or physician refusal to enroll in the study
- Patient with known CYP2C19 genotype prior to randomization
- Planned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure
- Anticipated discontinuation of clopidogrel or ticagrelor within the 12 month follow up period, example for elective surgery
- Serum creatinine >2.5 mg/dL within 7 days of index procedure
- Platelet count <80,000 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3 if persistent (at least 2 abnormal values) within 7 days prior to index procedure.
- History of intracranial hemorrhage
- Known hypersensitivity to clopidogrel or ticagrelor or any of its components
- Patient is participating in an investigational drug or device clinical trial that has not reached its primary endpoint
- Patient previously enrolled in this study
- Patient is pregnant, lactating, or planning to become pregnant within 12 months
- Patient has received an organ transplant or is on a waiting list for an organ transplant
- Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the procedure
- Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous, etc.)
- Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
- Concomitant use of simvastatin/lovastatin > 40 mg qd
- Concomitant use of potent CYP3A4 inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine)
- Non-cardiac condition limiting life expectancy to less than one year, per physician judgment (e.g. cancer)
- Known history of severe hepatic impairment
- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
- Inability to take aspirin at a dosage of 100 mg or less
- Current substance abuse (e.g., alcohol, cocaine, heroin, etc.)
Sites / Locations
- Mayo Clinic in Arizona
- Sharp HealthCare
- Zuckerberg San Francisco General
- Mayo Clinic in Florida
- NCH Heart Institute
- NorthShore University Health System
- Loyola University Medical Center
- St. Elizabeth Healthcare
- Henry Ford Hospital
- Essentia Institute of Rural Health
- Minneapolis Heart Institute
- University of Minnesota
- Mayo Clinic in Rochester
- The University of Mississippi Medical Center
- Albany Medical College
- The Feinstein Institute for Medical Research
- Winthrop University Hospital
- New York University Langone Medical Center
- Columbia University Medical Center
- Cardiology Associates of Schenectady
- Rhode Island Hospital
- The Miriam Hospital
- Greenville Health System
- MHS, Eau Claire
- Mayo Clinic Health System
- Aurora Health Care
- Vancouver General Hospital, UBC Division of Cardiology
- University of Ottawa Heart Institute
- Thunder Bay Regional Health Sciences Centre
- Humber River Hospital
- Sunnybrook Health Services Center
- St Michael's Hospital
- Toronto General Hospital - UHN
- Regina General Hospital
- Konyang University College of Medicine
- Chonnam National University Hospital
- Ajou University Hospital
- Chung-Ang University Hospital
- Hospital de Especialidades, Centro Medico Nacional 'La Raza'
- Hospital REgional No. 1
- Hospital de Cardiologia, Centro Medico Nacional Siglo XXI
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Genotype-Guided Therapy
Conventional Therapy
Subjects will be genotyped prospectively for CYP2C19*2, *3 and *17 alleles and will receive treatment based on their genotype. In this group, patients who have the CYP2C19 reduced function allele [i.e., *2 allele (heterozygous or homozygous) or *3 allele (heterozygous or homozygous)] patients will receive ticagrelor 90 mg bid. The WT YP2C19 patients will receive clopidogrel 75 mg once daily.
Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19*2, *3 and *17 alleles after completion of one year of treatment with clopidogrel.