Rivaroxaban Compared to Vitamin K Antagonist Upon Development of Cardiovascular Calcification

Exclusion Criteria

• •1. Patient has any clinical condition which does not allow initiation of long-term OAT including all contraindications such as hypersensitivity to active ingredient or other excipients, clinically relevant acute bleedings and all other risk circumstances according to Summary of Medicinal Product (SmPC) in which all warnings and preventive measures and precautions are described and have to be kept.
• •2. Hypersensitivity to active substances investigated or to any of the excipients
• •3. Patients had a previous coronary stent implantation in a way which makes coronary artery calcification scoring impossible or unreliable and no Valvular Calcification with Agatston Score \> 50
• •4. Chronic kidney disease (CKD) Stage V (GFR \<15 mL)
• •5. Liver disease with coagulopathy or other bleeding disorders including cirrhotic patients with Child Pugh B and C
• •6. Acute gastrointestinal diseases
• •7. Clinically significant active bleeding
• •8. Alcohol, opioids or drug abuse
• •9. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• •10. Patient is unwilling or unable to give informed consent
• •11. Patient is unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
• •12. Participation in a parallel interventional clinical trial
• •13. Patient has been committed to an institution by legal or regulatory order
• •14. Pregnant or lactating women
• •15. Female patient capable of bearing children without highly effective methods of birth control
• •16. Patient receives concomitant treatment with strong concurrent Cytochrome P 450 3A4 (CYP3A4)- and P- glycoprotein (P-gp)- inhibitors, i.e. azole-antimycotics (ketoconazole, itraconazole) or human immunodeficiency virus (HIV) protease inhibitors
• •17. Neuraxial Anaesthesia or spinal/epidural puncture
• •18. Known Endocarditis
• •19. Known Lactose intolerance