The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (CAPITAL PCI AF)

This is an interventional prevention trial for Atrial Fibrillation focused on measuring percutaneous coronary intervention, bleeding, atrial fibrillation, Ticagrelor, Rivaroxaban Read More

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 index PCI.

   • AF is defined by its presence on an electrocardiogram (ECG), Holter monitor, or any 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 atrial flutter is not much different from that in AF. Furthermore, many patients diagnosed with atrial flutter subsequently develop AF. Hence, current guidelines recommend that OAC should be 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 the presence 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 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