INR Control and Atrial Fibrillation in Primary Care in Spain (PAULA)
NCT ID: NCT02273609
Last Updated: 2014-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1524 participants
OBSERVATIONAL
2014-02-28
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies
NCT02610153
Anticoagulation Preference by AF Patients Study
NCT02607371
An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres
NCT02470767
Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea
NCT02810509
Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA
NCT02657616
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Participating in a clinical trial in the last 12 months.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Vivencio Barrios
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vivencio Barrios
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vivencio Barrios, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Ramon y Cajal
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BAY-AVK-2013-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.