EUROSAF
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)
Sponsor study identifier
Secondary identifiers
OTHER · Ethics Commitee of the Liguria Region
observational
3,000
1 country
1
Study Start
November 18, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Preliminary data suggest that:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2016
Actual (reported)November 18, 2016
Date type not reportedThis date has not been verified as actual or estimated.
November 28, 2016
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
all-cause mortality and vascular mortality
Vascular mortality is defined as: stroke, embolism, myocardial infarction
12 months
thromboembolic events,
stroke and/or systemic embolism
12 months
bleeding side-effects
major intracranial and gastrointestinal bleeding.
12 months
vascular-related hospitalization rates
12 months
bleeding-related hospitalization rates
12 months
MPI value and different mortality risk class
12 months
presence/absence of anticoagulant treatments
12 months
This is a cross-national, prospective, observational study that will include about 3.000 older subjects (aged ≥ 65 years) with AF hospitalized in 30 European geriatric centers (about 100 subjects/center) for an acute disease or a relapse of a chronic diseases. The study is in the frame of the Special Interest Group on CGA (Comprehensive Geriatric Assessment) of the EUGMS (European Union Geriatric Medicine Society).
S.C. Geriatria
Genova, 16128, Italy
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.
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.
Alberto Pilotto, MD
Dipartimento: area delle cure geriatriche, ortogeriatria e riabilitazione - E.O. Ospedali Galliera - Genova Italy
First Submitted
October 24, 2016
First Posted
November 28, 2016
Study Start
November 18, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2024
Screening for Actionable Atrial Fibrillation During Preoperative Consultation With the MyDiagnostick
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pilotto A, Veronese N, Polidori MC, Strandberg T, Topinkova E, Cruz-Jentoft AJ, Custodero C, Maggi S; EUROSAF Study Investigators. The role of prognostic stratification on prescription of anticoagulants in older patients with atrial fibrillation: a multicenter, observational, prospective European study (EUROSAF). Ann Med. 2022 Dec;54(1):2411-2419. doi: 10.1080/07853890.2022.2117407.
Veronese N, Argusti A, Canepa E, Polidori MC, Maggi S, Strandberg T, Pilotto A; EUROSAF Study Investigators. Evaluating the effectiveness and risks of oral anticoagulant treatments in multimorbid frail older subjects with atrial fibrillation using the multidimensional prognostic index: the EURopean study of older subjects with atrial fibrillation-EUROSAF. Eur Geriatr Med. 2018 Apr;9(2):149-154. doi: 10.1007/s41999-018-0026-6. Epub 2018 Feb 27.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 7, 2023
Record last verified: 2023-09
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