Atrial Fibrillation and FlutterPAULANCT02273609
INR Control and Atrial Fibrillation in Primary Care in Spain (PAULA)
An observational study of Atrial Fibrillation and Flutter, run by Vivencio Barrios.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation and Flutter
- What is being tested?
- Vitamin K antagonists (acenocoumarol or warfarin)
- How many people
- 1,524 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients that do not sign or understand written consent.
- Participating in a clinical trial in the last 12 months.
About this study
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.
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.
Read more
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation and Flutter
- Being tested
- Vitamin K antagonists (acenocoumarol or warfarin)
- Keywords
- Atrial fibrillation, Anticoagulation, Vitamin K antagonists, INR control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K antagonists (acenocoumarol or warfarin)Drug
Also called acenocoumarol; 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation and FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivencio Barrios
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Vivencio Barrios, Hospital Universitario Ramon y Cajal
- Investigators
- Vivencio Barrios, MD, PhD, Principal investigator, Hospital Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273609
- Sponsor's protocol ID
- BAY-AVK-2013-01
- Acronym
- PAULA
- Status last verified
- Oct 2014
- First submitted
- 18 Oct 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21901239Morgan 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.
PubMed 19062079Ansell 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.
PubMed 17221328Clua 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.
PubMed 15546539Hess 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.
PubMed 25173533Lobos-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.
PubMed 23683967Melamed 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.
PubMed 21504259Boulanger 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.
PubMed 16494639Hylek 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.
PubMed 12968085
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02273609
- Acronym / sponsor ID
- PAULA / BAY-AVK-2013-01
- Conditions
- Atrial Fibrillation and Flutter
- Keywords
- Atrial fibrillation, Anticoagulation, Vitamin K antagonists, INR control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,524 participants (actual)
- Lead sponsor
- Vivencio BarriosUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients that do not sign or understand written consent.
- Participating in a clinical trial in the last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K antagonists (acenocoumarol or warfarin)Also: acenocoumarol; warfarinINR 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. | Drug | – |
Primary outcome
Anticoagulation control with vitamin K antagonists
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Results publication: PubMed 21901239Gallagher 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.
- Results publication: PubMed 19062079Morgan 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.
- Results publication: PubMed 17221328Ansell 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.
- Results publication: PubMed 15546539Clua 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.
- Results publication: PubMed 25173533Hess 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.
- Results publication: PubMed 23683967Lobos-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.
- Results publication: PubMed 21504259Melamed 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.
- Results publication: PubMed 16494639Boulanger 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.
- Results publication: PubMed 12968085Hylek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivencio Barrios, MD, PhD principal investigator
Hospital Ramon y Cajal
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Flutter, run by Vivencio Barrios.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticoagulation control with vitamin K antagonists (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02273609, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.