AVKetcomorbid: Factors Associated to the Instability of the INR (International Normalized Ratio ) in the Prevention of Thromboembolism AVK (Anti Vitamin K) in Atrial Fibrillation in the Elderly: Instead of Comorbidities

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02841475
Collaborator
(none)
2,164
3

Study Details

Study Description

Brief Summary

Atrial fibrillation (AF) is a common condition whose prevalence increases with advancing age . One of the main complications of this arrhythmia is the occurrence of systemic thromboembolism, the first of which the occurrence of cerebrovascular accident (CVA) . The advanced age itself is an independent risk factor for occurrence of stroke in the context of AF , evidenced by the score awarded to the age over 75 years in the risk estimate thromboembolism in the score CHA2DS2-Vasc . Making the elderly a priority target for the prevention of thromboembolism, both because of the increased thromboembolic risk and prevalence of AF in this population. For many years, vitamin K antagonists (VKA) have proven their effectiveness in this context . But the effectiveness and safety of thromboembolism prevention by anti-vitamin K treatment involves maintaining the INR (International Normalized Ratio) in the therapeutic range. Indeed occurred of a thromboembolic or haemorrhagic adverse event directly correlates to having an INR outside the therapeutic range and maintaining the INR in the therapeutic range is subject to many variations inter- and intra-individual. They include, genetic factors , food , drug interactions , as well as disease processes . Or one of the elderly characteristics is the coexistence of multiple pathological processes or comorbidities . The supposed interaction between comorbidities and variability of INR has been little studied: Only a few studies have examined the factors associated with the stability of the INR and unstable . The identification of patients at risk of instability INR yet allow clinicians greater vigilance and better identification of patients for whom the initiation of treatment with vitamin K does not appear the best therapeutic strategy.

Our study seeks to determine whether comorbidity, assessed by the Charlson comorbidity index, are associated with instability of the INR, among more than 80 years for patients treated with AVK atrial fibrillation.

Condition or Disease Intervention/Treatment Phase
  • Other: Charlson comorbidity index

Study Design

Study Type:
Observational
Actual Enrollment :
2164 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Charlson comorbidity index [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients aged 80 years or more;

  • Patients present in geriatric structure June 21, 2011 ( short geriatric , SSR , LTC or nursing homes ) ;

  • Patients with AVK June 21, 2011 or having received warfarin in the previous 7 days ;

  • Patients with AVK under thromboembolism prevention in atrial fibrillation .

Exclusion Criteria:
    • Patients receiving AVK for another reason thromboembolism prevention for atrial fibrillation : treatment of venous thromboembolism , pulmonary embolism, mechanical heart valve , etc

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02841475
Other Study ID Numbers:
  • RC13_0409
First Posted:
Jul 22, 2016
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021