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

NCT02273609 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1524

Last updated 2014-10-29

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation and Flutter

Interventions

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Vivencio Barrios

    lead OTHER

Principal Investigators

  • Vivencio Barrios, MD, PhD · Hospital Ramon y Cajal

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-07-31
Completion
2014-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02273609 on ClinicalTrials.gov