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

Atrial Fibrillation and Flutter Clinical Trial

— PAULA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273609
• Other study ID #: BAY-AVK-2013-01
• Status: Completed
• Phase: N/A
• First received: October 18, 2014
• Last updated: October 28, 2014
• Start date: February 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1524
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation and Flutter
• Atrial Flutter

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vivencio Barrios	Bayer

References & Publications (9)

Ansell J, Hollowell J, Pengo V, Martinez-Brotons F, Caro J, Drouet L. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the international stu — View Citation

Boulanger L, Kim J, Friedman M, Hauch O, Foster T, Menzin J. Patterns of use of antithrombotic therapy and quality of anticoagulation among patients with non-valvular atrial fibrillation in clinical practice. Int J Clin Pract. 2006 Mar;60(3):258-64. — View Citation

Clua Espuny JL, Dalmau Llorca MR, Aguilar Martín C; Grupo de Trabajo. [Characteristics of oral anti-coagulation treatment in high-risk chronic auricular fibrillation]. Aten Primaria. 2004 Nov 15;34(8):414-9. Spanish. — View Citation

Gallagher AM, Setakis E, Plumb JM, Clemens A, van Staa TP. Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost. 2011 Nov;106(5):968-77. doi: 10.1160/TH11-05-0353. Epub 2011 Sep 8. — View Citation

Hess PL, Mirro MJ, Diener HC, Eikelboom JW, Al-Khatib SM, Hylek EM, Bosworth HB, Gersh BJ, Singer DE, Flaker G, Mega JL, Peterson ED, Rumsfeld JS, Steinberg BA, Kakkar AK, Califf RM, Granger CB; Atrial Fibrillation Think-Tank Participants. Addressing barr — View Citation

Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. — View Citation

Lobos-Bejarano JM, del Castillo-Rodríguez JC, Mena-González A, Alemán-Sánchez JJ, Cabrera de León A, Barón-Esquivias G, Pastor-Fuentes A; en nombre de los Investigadores del Estudio FIATE (Situación actual de la FIbrilación auricular en ATención primaria — View Citation

Melamed OC, Horowitz G, Elhayany A, Vinker S. Quality of anticoagulation control among patients with atrial fibrillation. Am J Manag Care. 2011 Mar;17(3):232-7. — View Citation

Morgan CL, McEwan P, Tukiendorf A, Robinson PA, Clemens A, Plumb JM. Warfarin treatment in patients with atrial fibrillation: observing outcomes associated with varying levels of INR control. Thromb Res. 2009 May;124(1):37-41. doi: 10.1016/j.thromres.2008 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anticoagulation control with vitamin K antagonists	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.	12 months	Yes