Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation (NCT02161965) | Clinical Trial Compass
CompletedPhase 4
Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation
France51 participantsStarted 2013-05-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. uncooperati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.