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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivencio Barrios
• Collaborator: Bayer
• Treatments: Acenocoumarol; Vitamin K; Vitamins; Warfarin

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.