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Trial record 14 of 156 for:    warfarin AND Vitamin K

Effect on Calcification of Replacing Warfarin by Rivaroxaban With or Without Vit K2 Supplements in HD; Extension Study

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ClinicalTrials.gov Identifier: NCT03799822
Recruitment Status : Active, not recruiting
First Posted : January 10, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Rogier Caluwe, Onze Lieve Vrouw Hospital

Brief Summary:

The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.


Condition or disease Intervention/treatment Phase
Vascular Calcification Drug: Rivaroxaban 10 MG Oral Tablet Dietary Supplement: MK-7 2000µg thrice weekly Drug: Vitamin K Antagonist - Drug Phase 4

Detailed Description:

The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Replacement of Vitamin K Antagonist by Rivaroxaban With or Without Vitamin K2 Supplementation on Vascular Calcifications in Chronic Hemodialysis Patients: a Randomized Controlled Trial, Extension Study
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Hemodialysis patients with non valvular atrial fibrillation receiving warfarin
Drug: Vitamin K Antagonist - Drug
treatment with a vitamin K antagonist

Experimental: rivaroxaban
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
Drug: Rivaroxaban 10 MG Oral Tablet
replacement of warfarin by rivaroxaban

Experimental: rivaroxaban + K2
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
Drug: Rivaroxaban 10 MG Oral Tablet
replacement of warfarin by rivaroxaban

Dietary Supplement: MK-7 2000µg thrice weekly
dietary supplement of vitamin K2 MK-7 2000µg thrice weekly




Primary Outcome Measures :
  1. bleeding incidence [ Time Frame: through study completion, on average 3 years ]
    minor or major bleeding


Secondary Outcome Measures :
  1. death rate [ Time Frame: through study completion, on average 3 years ]
    cause of death

  2. incidence of cardiovascular events [ Time Frame: through study completion, on average 3 years ]
    type of cardiovascular event



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • inclusion in the trial with clinicaltrials.gov identifier NCT02610933
  • signed informed consent for this extension trial

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799822


Locations
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Belgium
OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
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Principal Investigator: Rogier Caluwe, MD OLV Hospital Aalst, Belgium

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Responsible Party: Rogier Caluwe, Principal Investigator, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT03799822     History of Changes
Other Study ID Numbers: OLV 2014/065
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rogier Caluwe, Onze Lieve Vrouw Hospital:
hemodialysis
rivaroxaban
vitamin K2
Additional relevant MeSH terms:
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Vitamins
Vitamin K
Vitamin K 2
Warfarin
Vitamin MK 7
Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Rivaroxaban
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants