The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention

Exclusion Criteria

• •1. Age \<18 years old
• •2. Any condition that contraindicates anticoagulant therapy or would confer an unacceptable risk of bleeding, such as, but not limited to:
• •i. active internal bleeding, ii. bleeding at a non-compressible site, iii. bleeding diathesis within 30 days of PCI, iv. baseline platelet count \<90,000/μL, v. history of intracranial hemorrhage, vi. clinically significant gastrointestinal bleeding within 12 months of PCI, vii. baseline INR \> 1.5 in patients not prescribed VKA, suggesting underlying coagulation disorder.
• •3. History of stroke
• •4. Cardiogenic shock at the time of screening
• •5. Ventricular arrhythmias refractory to treatment at the time of screening
• •6. Calculated CrCl \<30 mL/min at the time of screening
• •7. Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening: alanine transaminase (ALT) \>5 times the upper limit of normal or ALT \>3 times the upper limit of normal plus total bilirubin \>2 times the upper limit of normal
• •8. Hemoglobin level \<90 g/dL at screening
• •9. Any severe condition that would limit life expectancy to less than 12 months
• •10. Major surgery, biopsy of a parenchymal organ, or serious trauma within the past 30 days
• •11. Incomplete staged PCI procedure (once completion of the staged PCI has occurred, the final PCI may become the index event)
• •12. CABG planned
• •13. Transient AF caused by a reversible disorder (e.g. thyrotoxicosis, pulmonary embolism, recent surgery)
• •14. Any condition other than non-valvular AF requiring long-term anticoagulation with VKAs such as moderate to severe mitral valve stenosis, mechanical heart valves, deep vein thrombosis, pulmonary embolism, or left ventricular thrombus
• •15. Known allergies, hypersensitivity, or intolerance to rivaroxaban or ticagrelor
• •16. Pregnant or planning to become pregnant while enrolled in this study, or unwilling to employ an investigator-approved method of birth control
• •17. Participation in a study with another investigational device or drug \< four weeks
• •18. Is receiving systemic treatment with strong inhibitors of both cytochrome P450 (CYP) 3A4 and p-glycoprotein (P-gp; eg, the azole-antimycotic ketoconazole and the HIV-protease inhibitor ritonavir). Treatment with fluconazole is allowed.
• •19. CHADS-VASC \<1