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Completed

NCT Number: NCT02841475

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

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Charlson comorbidity index

Other

Charlson comorbidity index

Primary outcomes

  1. Charlson comorbidity index

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: AVKetcomorbid

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2016
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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