Overview

Rivaroxaban Compared to Vitamin K Antagonist Upon Development of Cardiovascular Calcification

Status:
Completed

Trial end date:
2020-03-01

Target enrollment:
0

Participant gender:
All

Summary

The following trial hypothesis will be proved: In patients with atrial fibrillation and/ or pulmonary embolism standard anticoagulant treatment with coumadin/phenprocoumon is associated with accelerated coronary or valvular calcification as assessed by cardiac computed tomography compared to the new anticoagulant therapy with rivaroxaban.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

RWTH Aachen University

Collaborator:

Bayer

Treatments:

Phenprocoumon
Rivaroxaban
Vitamin K

Criteria

Inclusion Criteria:

1. Male or female patient aged > 18 years

2. Need for long-term OAT according to current international guidelines for the treatment
of atrial fibrillation (ACC/(American Heart Association [AHA]/ European Society of
Cardiology [ESC]guidelines) and / or pulmonary embolism (ACCP/ESC guidelines).

3. Existent Coronary or Valvular Calcification, or both and an Agatston Score > 50 in at
least one location as assessed by MSCT at Screening

4. The anticipated minimum life expectancy is18 months

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