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Trial record 13 of 156 for:    warfarin AND Vitamin K

INR Control and Atrial Fibrillation in Primary Care in Spain (PAULA) (PAULA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273609
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 29, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Vivencio Barrios, Hospital Universitario Ramon y Cajal

Brief Summary:

The primary objective of this study was to determine rates of INR control of patients with nonvalvular AF daily attended in primary care in Spain.

PAULA is an observational retrospective/cross-sectional and multicenter study. Patients aged ≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care were included in the study. To be included, at least 80% of INR values during the past 12 months should be available. Before inclusion, patients provided written consent.

Clinical data (biodemographic data, comorbidities, treatments, and thromboembolic/bleeding risk) were recorded from the clinical history of patients at the moment of inclusion. INR values were taken from the previous 12 months of inclusion.

Poor INR control was considered when percent time in therapeutic INR range (TTR) was <65% (calculated by Rosendaal method) or <60% by direct method (proportion of INR values).

A total of 1,524 patients have been included in the study.


Condition or disease Intervention/treatment
Atrial Fibrillation and Flutter Drug: Vitamin K antagonists (acenocoumarol or warfarin)

Detailed Description:

Vitamin K antagonists (VKAs) have traditionally been used for long-term prevention of thromboembolic complications in patients with atrial fibrillation (AF). Because of the variability in the dose response with VKAs and the narrow therapeutic window, monitoring the degree of anticoagulation is mandatory. The international normalized ratio (INR) provides a standardized measure of the VKA anticoagulant effect. The INR should be kept within a narrow range (therapeutic INR target 2.0-3.0) to control the intensity of anticoagulation.

The primary objective of this study was to determine rates of INR control of patients with nonvalvular AF daily attended in primary care in Spain.

PAULA is an observational retrospective/cross-sectional and multicenter study supported by the three main Spanish primary care scientific societies: Sociedad Española de Médicos de Atención Primaria (SEMERGEN), Sociedad Española de Medicina de Familia y Comunitaria (SEMFYC) and Sociedad Española de Médicos Generales y de Familia (SEMG).

Patients aged ≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care were included in the study. To be included, at least 80% of INR values during the past 12 months should be available. Before inclusion, patients provided written consent.

Clinical data (biodemographic data, comorbidities, treatments, and thromboembolic/bleeding risk) were recorded from the clinical history of patients at the moment of inclusion. INR values were taken from the previous 12 months of inclusion.

Poor INR control was considered when percent time in therapeutic INR range (TTR) was <65% (calculated by Rosendaal method) or <60% by direct method (proportion of INR values).

The study was approved by the ethics committee of hospital La Paz, Madrid.

A total of 1,524 patients have been included in the study.


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Study Type : Observational
Actual Enrollment : 1524 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: English: Current Perspective of the Status of Anticoagulation in Clinical Practice in Primare Care. Spanish: Perspectiva Actual de la sitUación de la anticoaguLación en la práctica clínica de Atención Primaria.
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Vitamin K antagonists (acenocoumarol or warfarin)

    INR values of patients treated with acenocoumarol or warfarin in the last 12 months will be recorded according to clinical practice of each center.

    No specific recommendation about treatment will be provided by sponsor.

    Other Name: acenocoumarol; warfarin


Primary Outcome Measures :
  1. Anticoagulation control with vitamin K antagonists [ Time Frame: 12 months ]
    international normalized ratio (INR) provides a standardized measure of the VKA anticoagulant effect. INR values of patients treated with acenocoumarol or warfarin in the last 12 months will be recorded according to clinical practice of each center.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged ≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care setting were included in the study.
Criteria

Inclusion Criteria:

  • Patients aged ≥18 years old with
  • nonvalvular AF,
  • treated with VKAs for at least one year in primary care
  • At least 80% of INR values during the past 12 months should be available.
  • Written consent should be provided before inclusion.

Exclusion Criteria:

  • Patients that do not sign or understand written consent.
  • Participating in a clinical trial in the last 12 months.

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): NCT02273609


Sponsors and Collaborators
Vivencio Barrios
Bayer
Investigators
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Principal Investigator: Vivencio Barrios, MD, PhD Hospital Ramon y Cajal

Publications of Results:

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Responsible Party: Vivencio Barrios, MD, PhD, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02273609     History of Changes
Other Study ID Numbers: BAY-AVK-2013-01
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by Vivencio Barrios, Hospital Universitario Ramon y Cajal:
Atrial fibrillation
Anticoagulation
Vitamin K antagonists
INR control
Additional relevant MeSH terms:
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Vitamins
Vitamin K
Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acenocoumarol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants