Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation

• Status: Completed
• Trial end date: 2018-02-16
• Target enrollment: 0
• Participant gender: All

Summary

The VICTORIA Study (Vascular CalcIfiCation and sTiffness induced by ORal antIcoAgulation) is a comparative, parallel, prospective, controlled and randomized study of the structural and functional impact of rivaroxaban versus anti-vitamin K drugs on the arterial vasculature.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Treatments: Fluindione; Phenindione; Rivaroxaban; Vitamin K; Warfarin

Criteria

Inclusion Criteria:

• Male or female patient aged > 18 years

• Female patient capable of bearing children with highly effective methods of birth control

• Creatinine clearance > 30 ml/min

• Normal hepatic function based on hepatic enzymes

• Treated for atrial fibrillation according a score superior at 1

• Treatment duration 12 months according to the actual recommendations

• Treated by vitamine K antagonist less than 2 months before entering the study

• Patient willing to participate with a signed informed consent

• Patient covered by a healthcare insurance

Exclusion Criteria:

• Patient has any clinical condition which does not allow initiation of long-term 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 in which all warnings and preventive measures and precautions are described and have to be kept.

• Patients had a previous coronary stent implantation

• Creatinine clairance <30 mL)

• Liver disease with coagulopathy or other bleeding disorders including cirrhotic patients with Child Pugh

• Hyperthryroidism

• Hypercalcemia

• Hyperphosphatemia

• Acute gastrointestinal diseases

• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

• Patient is unwilling or unable to give informed consent

• Patient is unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

• Participation in a parallel interventional clinical trial

• Patient has been committed to an institution by legal or regulatory order

• Pregnant or lactating women

• Female patient capable of bearing children without highly effective methods of birth control

• Patient with history of myocardial infarction and/or coronary disease.