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

NCT02273609 | Completed DMC

• 1 other identifier: BAY-AVK-2013-01
• Study Type: observational
• Target: 1,524
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation and Flutter

Keywords

Atrial fibrillation; Anticoagulation; Vitamin K antagonists; INR control

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Vitamin K antagonists (acenocoumarol or warfarin) DRUG

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.

Also known as: acenocoumarol; warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vivencio Barrios: lead
• Bayer: collaborator

Related Publications (9)

• 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.

  PMID: 21901239 RESULT

• 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.2008.09.016. Epub 2008 Dec 4.

  PMID: 19062079 RESULT

• 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 study of anticoagulation management (ISAM). J Thromb Thrombolysis. 2007 Apr;23(2):83-91. doi: 10.1007/s11239-006-9022-7.

  PMID: 17221328 RESULT

• Clua Espuny JL, Dalmau Llorca MR, Aguilar Martin 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. doi: 10.1016/s0212-6567(04)78925-8. Spanish.

  PMID: 15546539 RESULT

• 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 barriers to optimal oral anticoagulation use and persistence among patients with atrial fibrillation: Proceedings, Washington, DC, December 3-4, 2012. Am Heart J. 2014 Sep;168(3):239-247.e1. doi: 10.1016/j.ahj.2014.04.007. Epub 2014 Apr 24.

  PMID: 25173533 RESULT

• Lobos-Bejarano JM, del Castillo-Rodriguez JC, Mena-Gonzalez A, Aleman-Sanchez JJ, Cabrera de Leon A, Baron-Esquivias G, Pastor-Fuentes A; en nombre de los Investigadores del Estudio FIATE (Situacion actual de la FIbrilacion auricular en ATencion primaria en Espana). [Patients' characteristics and clinical management of atrial fibrillation in primary healthcare in Spain: FIATE Study]. Med Clin (Barc). 2013 Oct 5;141(7):279-86. doi: 10.1016/j.medcli.2012.12.023. Epub 2013 May 15. Spanish.

  PMID: 23683967 RESULT

• 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.

  PMID: 21504259 RESULT

• 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. doi: 10.1111/j.1368-5031.2006.00790.x.

  PMID: 16494639 RESULT

• 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. doi: 10.1056/NEJMoa022913.

  PMID: 12968085 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Acenocoumarol; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Vivencio Barrios, MD, PhD

  Hospital Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 18, 2014
• First Posted: October 24, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 29, 2014

Record last verified: 2014-10