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

Inclusion Criteria:

1. Patient has undergone a PCI with stent placement, plus
2. Documented non-valvular atrial fibrillation (AF)* within 1 year before screening, OR >1 year before screening if patient had been receiving oral anticoagulation (OAC)therapy for the atrial fibrillation for 3 months immediately before the indexPCI.

• AF is defined by its presence on an electrocardiogram (ECG), Holter monitor, orany device that provides a rhythm strip documenting paroxysmal, persistent or,permanent atrial fibrillation. Atrial flutter can be included as "AF equivalent". The stroke risk in patients with atrialflutter is not much different from that in AF. Furthermore, many patients diagnosed withatrial flutter subsequently develop AF. Hence, current guidelines recommend that OAC shouldbe used in patients with atrial flutter similar to that in patients with AF. Non-valvular AF is defined as the absence of moderate to severe mitral stenosis or thepresence of a mechanical valve as per 2016 ESC guidelines.

Exclusion Criteria:

1. Age <18 years old
2. Any condition that contraindicates anticoagulant therapy or would confer anunacceptable risk of bleeding, such as, but not limited to: i. active internal bleeding, ii. bleeding at a non-compressible site, iii. bleedingdiathesis within 30 days of PCI, iv. baseline platelet count <90,000/μL, v. history ofintracranial hemorrhage, vi. clinically significant gastrointestinal bleeding within 12 months of PCI, vii. baseline INR > 1.5 in patients not prescribed VKA, suggestingunderlying 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: alaninetransaminase (ALT) >5 times the upper limit of normal or ALT >3 times the upper limitof 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 30days
11. Incomplete staged PCI procedure (once completion of the staged PCI has occurred, thefinal 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 VKAssuch as moderate to severe mitral valve stenosis, mechanical heart valves, deep veinthrombosis, 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 toemploy 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 theHIV-protease inhibitor ritonavir). Treatment with fluconazole is allowed.
19. CHADS-VASC <1