At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
An observational study evaluating Vitamin K antagonists (acenocoumarol or warfarin) for Atrial Fibrillation and Flutter. Completed, enrolled 1,524 participants.
Detailed 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.
Study Details
Timeline
Interventions
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.