Atrial Fibrillation or Pulmonary Embolism Clinical Trial
Official title:
Influence of Rivaroxaban Compared to Vitamin K Antagonist Treatment Upon Development of Cardiovascular Calcification in Patients With Atrial Fibrillation and/ or Pulmonary Embolism (IRIVASC- Trial)
| NCT number | NCT02066662 |
| Other study ID # | 12-001 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | July 2013 |
| Est. completion date | March 2020 |
| Verified date | October 2020 |
| Source | RWTH Aachen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 192 |
| Est. completion date | March 2020 |
| Est. primary completion date | March 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Aachen, Department of Cardiology | Aachen | North Rhine Westphalia |
| Germany | Hospital Coburg, Med. Clinic II for Internal Medicine and Cardiology | Coburg | Bavaria |
| Germany | St.-Antonius-Hospital Eschweiler, Internal Medicine | Eschweiler | North Rhine Westphalia |
| Lead Sponsor | Collaborator |
|---|---|
| RWTH Aachen University | Bayer |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Occurrence of major cardiovascular complications (MACE) | 1 week, 1, 6, 9, 12 and 24 month FU | ||
| Other | Non- major bleedings | 1week, 1, 6, 9, 12 and 24 month FU | ||
| Other | Major bleedings | 1 week, 6, 9, 12 and 24 month FU | ||
| Primary | Progression of coronary and aortic valve calcification (Agatston, volume & mass score as assessed by cardiac CT) | To investigate the association of rivaroxaban compared to coumadin/phenprocoumon treatment for OAT in patients with atrial fibrillation and / or pulmonary embolism regarding the development and progression of coronary artery calcification (CAC) and aortic valve calcification (AVC) as assessed by multi-slice spiral computed. tomography scanning (MSCT) within one year follow-up | Cardiac Computertomography (CT) will be performed at screening, after 12 months and at 24 months | |
| Secondary | Serum chemistry including Matrix Gla Protein (MPG) level changes and Fetuin-A (baseline/ follow up) | baseline and 12 month Follow Up | ||
| Secondary | Changes in intima-media thickness of carotid artery (IMT) and flow-mediated vasodilation of brachial artery (FMD) | Baseline, 6, 12 and 24 month FU | ||
| Secondary | Progression of aortic calcification (aortic Agatston Score) | screening and 12 month FU | ||
| Secondary | Changes in ventricular diastolic function parameters as determined by echocardiography (strain/strain-rate imaging) | baseline, 6, 9, 12 and 24 month FU |