Trial Synopsis

Potential participants must have NONE of the following exclusion criteria at the time of study enrollment:

1. Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
2. Indication for, or contraindication to, anticoagulant therapy,
3. High bleeding risk including any coagulopathy,
4. Lesion or condition considered to be a significant risk of major bleeding,
5. Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding,
6. Current treatment with P2Y12 inhibitors/adenosine diphosphate (ADP) receptor inhibitors (clopidogrel, prasugrel, ticagrelor, cangrelor) or phosphodiesterase inhibitors (dipyridamole), where the treating physician or patient does not wish to stop these medications,
7. Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4,
8. Any stroke within 1 month prior to enrolment,
9. Any previous history of a haemorrhagic or lacunar stroke,
10. Severe heart failure with known ejection fraction <30% or NYHA class III or IV symptoms,
11. History of hypersensitivity or known contraindication to rivaroxaban,
12. Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg) at the time of screening,
13. Haemoglobin <90 g/L, or platelet count <100 x10⁹/L,
14. Significant liver disease (defined as Child-Pugh Class B or C) or ALT >3 times upper normal limit,
15. Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery,
16. All countries except Europe: Pregnancy or intention to become pregnant or breast-feeding, Europe only: Women who are not in a postmenopausal state, where postmenopausal is defined as no menses for 12 months without alternative medical causes,
17. Inability to understand or comply with the requirements of the study.