Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation

NCT02161965 | Completed Phase 4 DMC

• 1 other identifier: 2012-005354-27
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Permanent Atrial Fibrillation; Venous Thrombosis; Pulmonary Embolism; Anticoagulation Treatment at Least > or = to 12-month

Keywords

Anticoagulation; Coronary and peripheral calcification; Arterial stiffness; Biomarker

Outcome Measures

Primary Outcomes (1)

• Calcification score measured by CT scan

  Rate of coronary and lower Limb calcifications between oral inhibitor of Xa activity and vitamin K antagonists

  2 months

Secondary Outcomes (1)

• Arterial stiffness measured by ultrasounds

  3 months

Other Outcomes (1)

• Dosage of circulating anti-calcifying factors and extra-cellular matrix remodelling

  2 months

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Rivaroxaban (oral tablet) for patients with atrial fibrillation: 20 mg once daily for patients with GFR \> 49 ml per minute and 15 mg rivaroxaban once daily for patients with GFR of 15 to 49 ml. Rivaroxaban (oral tablet) for patients with pulmonary embolism: 2 x a day 15 mg at day 1-21 and 1x 20 mg from day 22 ongoing

Drug: Rivaroxaban

vitamin K antagonists

ACTIVE COMPARATOR

Adjusted dose of warfarin or fluindione (oral tablet) titrated according to target international normalized ratio with a target range 2.0 to 3.0.

Drug: Fluindione; Drug: Warfarin

Interventions

Rivaroxaban DRUG

20mg or 15mg

Also known as: Xarelto

Rivaroxaban

Fluindione DRUG

Also known as: Previscan

vitamin K antagonists

Warfarin DRUG

Also known as: Previscan

vitamin K antagonists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Rivaroxaban; fluindione; Warfarin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Georges LEFTHERIOTIS, MD, PhD

  University hospital, Angers, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 12, 2014
• Study Start: May 21, 2013
• Primary Completion: December 31, 2016
• Study Completion: February 16, 2018
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)