The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

Atrial Fibrillation Clinical Trial

— EUROSAF  

Official title:

Evaluating the Efficacy and Risks of Anticoagulant Treatments in Multimorbid Frail Older Subjects With Atrial Fibrillation. The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02973984
• Other study ID #: 28UCS2015
• Secondary ID: 162REG2016
• Status: Recruiting
• Start date: November 18, 2016
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Alberto Pilotto, MD
• Phone: 0039 010 563
• Email: alberto.pilotto[@]galliera.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Preliminary data suggest that:

1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF);

2. the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF;

3. considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.

Description:

The main objective of this observational study is to evaluate in a "real world" population of older hospitalized patients with AF, the clinical benefit/risk ratio of the anticoagulant treatments in terms of:

1. mortality (all-cause and vascular mortality);

2. thromboembolic events, i.e. stroke, systemic embolism;

3. bleeding side-effects, especially intracranial and gastrointestinal bleeding Secondary objective of the study is to evaluate whether a different prognostic profile, as determined by the MPI, is associated with 1) different kind of treatments for AF (no treatment vs anticoagulants, i.e. Vitamin K Antagonists (VKA) or novel oral anticoagulant (NOACs); and 2) differences in the main outcomes (i.e. mortality, major thromboembolic events and side effects including bleeding events).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

This is an observational study in which all consecutive patients admitted to the Geriatrics Units involved in the project will be screened for inclusion. The inclusion criteria are:

1. patients of both genders, aged 65 years and older

2. admitted to hospital for acute diseases or a relapse of chronic diseases

3. with a documented diagnosis of non valvular AF

4. who are willing to participate in the survey and give their informed consent

Exclusion Criteria:

1. age less than 65 years

2. patients who have not provided informed consent

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Italy	S.C. Geriatria	Genova

Sponsors (2)

Lead Sponsor	Collaborator
Alberto Pilotto	Bayer

Country where clinical trial is conducted

Italy, 

References & Publications (24)

Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Wann LS, Curtis AB, Ellenbogen KA, Estes NA 3rd, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Le Heuzey JY, Kay GN, Olsson SB, Prystowsky EN, Tamargo JL, Wann S. Management of patients with atrial fibrillation (compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS recommendations): a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 May 7;61(18):1935-44. doi: 10.1016/j.jacc.2013.02.001. Epub 2013 Apr 1. No abstract available. — View Citation

Angleman SB, Santoni G, Pilotto A, Fratiglioni L, Welmer AK; MPI_AGE Project Investigators. Multidimensional Prognostic Index in Association with Future Mortality and Number of Hospital Days in a Population-Based Sample of Older Adults: Results of the EU Funded MPI_AGE Project. PLoS One. 2015 Jul 29;10(7):e0133789. doi: 10.1371/journal.pone.0133789. eCollection 2015. — View Citation

Barco S, Cheung YW, Eikelboom JW, Coppens M. New oral anticoagulants in elderly patients. Best Pract Res Clin Haematol. 2013 Jun;26(2):215-24. doi: 10.1016/j.beha.2013.07.011. Epub 2013 Jul 21. — View Citation

Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available. Erratum In: Europace. 2011 Jul;13(7):1058. Dosage error in article text. — View Citation

Cerreta F, Eichler HG, Rasi G. Drug policy for an aging population--the European Medicines Agency's geriatric medicines strategy. N Engl J Med. 2012 Nov 22;367(21):1972-4. doi: 10.1056/NEJMp1209034. No abstract available. — View Citation

Crome P, Lally F, Cherubini A, Oristrell J, Beswick AD, Clarfield AM, Hertogh C, Lesauskaite V, Prada GI, Szczerbinska K, Topinkova E, Sinclair-Cohen J, Edbrooke D, Mills G. Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study. Drugs Aging. 2011 Aug 1;28(8):667-77. doi: 10.2165/11591990-000000000-00000. — View Citation

Gill TM. The central role of prognosis in clinical decision making. JAMA. 2012 Jan 11;307(2):199-200. doi: 10.1001/jama.2011.1992. No abstract available. — View Citation

Granziera S, Cohen AT, Nante G, Manzato E, Sergi G. Thromboembolic prevention in frail elderly patients with atrial fibrillation: a practical algorithm. J Am Med Dir Assoc. 2015 May 1;16(5):358-64. doi: 10.1016/j.jamda.2014.12.008. Epub 2015 Feb 11. — View Citation

Hylek EM, D'Antonio J, Evans-Molina C, Shea C, Henault LE, Regan S. Translating the results of randomized trials into clinical practice: the challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke. 2006 Apr;37(4):1075-80. doi: 10.1161/01.STR.0000209239.71702.ce. Epub 2006 Mar 9. — View Citation

Maes F, Dalleur O, Henrard S, Wouters D, Scavee C, Spinewine A, Boland B. Risk scores and geriatric profile: can they really help us in anticoagulation decision making among older patients suffering from atrial fibrillation? Clin Interv Aging. 2014 Jul 15;9:1091-9. doi: 10.2147/CIA.S62597. eCollection 2014. — View Citation

Olesen JB, Lip GY, Hansen ML, Hansen PR, Tolstrup JS, Lindhardsen J, Selmer C, Ahlehoff O, Olsen AM, Gislason GH, Torp-Pedersen C. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011 Jan 31;342:d124. doi: 10.1136/bmj.d124. — View Citation

Pilotto A, Ferrucci L, Franceschi M, D'Ambrosio LP, Scarcelli C, Cascavilla L, Paris F, Placentino G, Seripa D, Dallapiccola B, Leandro G. Development and validation of a multidimensional prognostic index for one-year mortality from comprehensive geriatric assessment in hospitalized older patients. Rejuvenation Res. 2008 Feb;11(1):151-61. doi: 10.1089/rej.2007.0569. — View Citation

Pilotto A, Gallina P, Fontana A, Sancarlo D, Bazzano S, Copetti M, Maggi S, Paroni G, Marcato F, Pellegrini F, Donato D, Ferrucci L. Development and validation of a Multidimensional Prognostic Index for mortality based on a standardized Multidimensional Assessment Schedule (MPI-SVaMA) in community-dwelling older subjects. J Am Med Dir Assoc. 2013 Apr;14(4):287-92. doi: 10.1016/j.jamda.2013.01.005. Epub 2013 Feb 9. — View Citation

Pilotto A, Panza F, Ferrucci L. A multidimensional prognostic index in common conditions leading to death in older patients. Arch Intern Med. 2012 Apr 9;172(7):594; discussion 594-5. doi: 10.1001/archinternmed.2011.1891. No abstract available. — View Citation

Pilotto A, Rengo F, Marchionni N, Sancarlo D, Fontana A, Panza F, Ferrucci L; FIRI-SIGG Study Group. Comparing the prognostic accuracy for all-cause mortality of frailty instruments: a multicentre 1-year follow-up in hospitalized older patients. PLoS One. 2012;7(1):e29090. doi: 10.1371/journal.pone.0029090. Epub 2012 Jan 11. — View Citation

Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18. — View Citation

Pugh D, Pugh J, Mead GE. Attitudes of physicians regarding anticoagulation for atrial fibrillation: a systematic review. Age Ageing. 2011 Nov;40(6):675-83. doi: 10.1093/ageing/afr097. Epub 2011 Aug 5. — View Citation

Sardar P, Chatterjee S, Chaudhari S, Lip GY. New oral anticoagulants in elderly adults: evidence from a meta-analysis of randomized trials. J Am Geriatr Soc. 2014 May;62(5):857-64. doi: 10.1111/jgs.12799. Epub 2014 May 1. — View Citation

Sinnaeve PR, Brueckmann M, Clemens A, Oldgren J, Eikelboom J, Healey JS. Stroke prevention in elderly patients with atrial fibrillation: challenges for anticoagulation. J Intern Med. 2012 Jan;271(1):15-24. doi: 10.1111/j.1365-2796.2011.02464.x. Epub 2011 Oct 31. — View Citation

Siontis GC, Tzoulaki I, Ioannidis JP. Predicting death: an empirical evaluation of predictive tools for mortality. Arch Intern Med. 2011 Oct 24;171(19):1721-6. doi: 10.1001/archinternmed.2011.334. Epub 2011 Jul 25. — View Citation

Stollberger C, Finsterer J. Concerns about the use of new oral anticoagulants for stroke prevention in elderly patients with atrial fibrillation. Drugs Aging. 2013 Dec;30(12):949-58. doi: 10.1007/s40266-013-0119-3. — View Citation

Volpato S, Bazzano S, Fontana A, Ferrucci L, Pilotto A; MPI-TriVeneto Study Group. Multidimensional Prognostic Index predicts mortality and length of stay during hospitalization in the older patients: a multicenter prospective study. J Gerontol A Biol Sci Med Sci. 2015 Mar;70(3):325-31. doi: 10.1093/gerona/glu167. Epub 2014 Sep 9. — View Citation

Yourman LC, Lee SJ, Schonberg MA, Widera EW, Smith AK. Prognostic indices for older adults: a systematic review. JAMA. 2012 Jan 11;307(2):182-92. doi: 10.1001/jama.2011.1966. — View Citation

Zarraga IG, Kron J. Oral anticoagulation in elderly adults with atrial fibrillation: integrating new options with old concepts. J Am Geriatr Soc. 2013 Jan;61(1):143-50. doi: 10.1111/jgs.12042. Epub 2012 Dec 18. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality and vascular mortality	Vascular mortality is defined as: stroke, embolism, myocardial infarction	12 months
Primary	thromboembolic events,	stroke and/or systemic embolism	12 months
Primary	bleeding side-effects	major intracranial and gastrointestinal bleeding.	12 months
Secondary	vascular-related hospitalization rates	stroke and/or systemic embolism	12 months
Secondary	bleeding-related hospitalization rates	intracranial and gastrointestinal bleeding	12 months
Secondary	MPI value and different mortality risk class	mild, moderate, severe	12 months
Secondary	presence/absence of anticoagulant treatments	presence of anticoagulant treatments	12 months