Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

Rivaroxaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk
of stroke in a similar population in comparison with warfarin. The rate of myocardial
infarction was 9% lower in the rivaroxaban group than in the warfarin group in the Rocket AF
study and similarly the myocardial infarction rate was 12% lower in the apixaban group in
Aristotle, but the difference was not significant in either trial. The potential of long term
benefit by avoiding VKA therapy may be much greater for a CV event reduction. The study
proposed will evaluate markers of CAC progression and atherosclerosis development, which have
long term outcome data supporting that slowing these processes will be associated with lower
CV events.

Key Inclusion Criteria:

1. Eligible patients with atrial fibrillation at enrollment or two or more episodes of
atrial fibrillation or flutter, as documented by electrocardiography, at least 2 weeks
apart in the 12 months before enrollment

2. Age 18-84

3. On Warfarin for 6 months prior to enrollment at a stable dose.

4. Willingness to participate in the study and ability to sign informed consent

5. Minimum CAC score of 10

Key Exclusion Criteria:

1. Atrial fibrillation due to a reversible cause, moderate or severe mitral stenosis, or
conditions other than atrial fibrillation that require anticoagulation (e.g., a
prosthetic heart valve)

2. Prior apixaban, dabigatran, rivaroxaban use.

3. A need for aspirin at a dose of >165 mg a day or for both aspirin and clopidogrel,

4. Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated
creatinine clearance of <50 ml per minute).

5. Serious bleeding event in the previous 6 months or a high risk of bleeding (eg, active
peptic ulcer disease, a platelet count of <100,000/mm3 or hemoglobin level of <10
g/dL, stroke within the previous 10 days, documented hemorrhagic tendencies, or blood
dyscrasias)

6. Weight in excess of 325 pounds

7. Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension
(systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg).

8. History of active malignancy requiring concurrent chemotherapy.

9. Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of
the principal investigator is likely to affect the subject's ability to complete the
study.

10. Known allergy to iodinated contrast material

11. Pregnancy or breast feeding