Viewing Study NCT03285100



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Last Modification Date: 2024-10-26 @ 12:31 PM
Study NCT ID: NCT03285100
Status: UNKNOWN
Last Update Posted: 2018-01-25
First Post: 2017-09-13

Brief Title: The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation
Sponsor: Canisius-Wilhelmina Hospital
Organization: Canisius-Wilhelmina Hospital

Study Overview

Official Title: Pilot Study to Assess the Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation
Status: UNKNOWN
Status Verified Date: 2018-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background Elastin is a unique protein providing elasticity resilience and deformability to dynamic tissues such as lungs and vasculature Elastin fibers are characterized by their high affinity for calcium However calcified elastin is more prone to the degrading effects of proteases and in turn partially degraded elastin has an even higher affinity for calcium A disturbed balance between proteases and anti-proteases is a major underlying mechanism in the development of chronic obstructive pulmonary disease COPD Virtually the only protein that can protect elastin from calcification is matrix Gla-protein MGP which needs vitamin K for its activation In COPD patients a lower vitamin K status is found when compared to control subjects and an inverse association exists between vitamin K status and elastin degradation In addition vitamin K status is lower and elastin degradation is accelerated in Vitamin K antagonist VKA users

VKAs are widely used Nowadays an increasing number of patients uses direct oral anticoagulants DOACs which do not influence vitamin K status The hypothesis of this study is that discontinuation of VKAs results in an improved vitamin K status and deceleration of elastin degradation In order to test this hypothesis an observational pilot study will be conducted in which the change in elastin degradation- quantified by plasma desmosine concentrations - in patients who discontinue use of VKAs will be used as primary endpoint

Study design Observational study Study population A total of 30 VKA users who will discontinue the use of VKAs Elastin degradation rate quantified by plasma desmosine levels and vitamin K status quantified by measuring plasma levels of dephosphorylated uncarboxylated dp-ucMGP will be measured during the use of VKAs and approximately 6 months after discontinuation of VKAs Furthermore the VKORC1 polymorphisms will be determined

Main study parameters The primary endpoint is the change in the rate of elastin degradation quantified by the plasma desmosine assay Secondary endpoints are the change in vitamin K status quantified by measuring plasma levels of dp-ucMGP the relation between desmosine and dp-ucMGP and differences of desmosine and dp-ucMGP levels among subjects with different polymorphisms of the vitamin K 23-epoxide reductase complex 1 VKORC1 gene
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None