Tailored Antiplatelet Therapy Following PCI

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.)