Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study

Background. We investigated low-dose aspirin (ASA) efficacy and safety in subjects with silent brain infarcts (SBIs) in preventing new cerebrovascular (CVD) events as well as cognitive impairment. Methods. We included subjects aged ≥45 years, with at least one SBI and no previous CVD. Subjects were...

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Main Authors: Ilaria Maestrini, Marta Altieri, Laura Di Clemente, Edoardo Vicenzini, Patrizia Pantano, Eytan Raz, Mauro Silvestrini, Leandro Provinciali, Isabella Paolino, Carmine Marini, Matteo Di Giuseppe, Tommasina Russo, Francesco Federico, Cristiana Coppola, Maria Pia Prontera, Domenico Maria Mezzapesa, Vincenzo Lucivero, Lucilla Parnetti, Paola Sarchielli, Maria Peducci, Domenico Inzitari, Giovanna Carlucci, Carlo Serrati, Carla Zat, Anna Cavallini, Alessandra Persico, Giuseppe Micieli, Stefano Bastianello, Vittorio Di Piero
Format: Article
Language:English
Published: Wiley 2018-01-01
Series:Stroke Research and Treatment
Online Access:http://dx.doi.org/10.1155/2018/7532403
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author Ilaria Maestrini
Marta Altieri
Laura Di Clemente
Edoardo Vicenzini
Patrizia Pantano
Eytan Raz
Mauro Silvestrini
Leandro Provinciali
Isabella Paolino
Carmine Marini
Matteo Di Giuseppe
Tommasina Russo
Francesco Federico
Cristiana Coppola
Maria Pia Prontera
Domenico Maria Mezzapesa
Vincenzo Lucivero
Lucilla Parnetti
Paola Sarchielli
Maria Peducci
Domenico Inzitari
Giovanna Carlucci
Carlo Serrati
Carla Zat
Anna Cavallini
Alessandra Persico
Giuseppe Micieli
Stefano Bastianello
Vittorio Di Piero
author_facet Ilaria Maestrini
Marta Altieri
Laura Di Clemente
Edoardo Vicenzini
Patrizia Pantano
Eytan Raz
Mauro Silvestrini
Leandro Provinciali
Isabella Paolino
Carmine Marini
Matteo Di Giuseppe
Tommasina Russo
Francesco Federico
Cristiana Coppola
Maria Pia Prontera
Domenico Maria Mezzapesa
Vincenzo Lucivero
Lucilla Parnetti
Paola Sarchielli
Maria Peducci
Domenico Inzitari
Giovanna Carlucci
Carlo Serrati
Carla Zat
Anna Cavallini
Alessandra Persico
Giuseppe Micieli
Stefano Bastianello
Vittorio Di Piero
author_sort Ilaria Maestrini
collection DOAJ
description Background. We investigated low-dose aspirin (ASA) efficacy and safety in subjects with silent brain infarcts (SBIs) in preventing new cerebrovascular (CVD) events as well as cognitive impairment. Methods. We included subjects aged ≥45 years, with at least one SBI and no previous CVD. Subjects were followed up to 4 years assessing CVD and SBI incidence as primary endpoint and as secondary endpoints: (a) cardiovascular and adverse events and (b) cognitive impairment. Results. Thirty-six subjects received ASA while 47 were untreated. Primary endpoint occurred in 9 controls (19.1%) versus 2 (5.6%) in the ASA group (p=0.10). Secondary endpoints did not differ in the two groups. Only baseline leukoaraiosis predicts primary [OR 5.4 (95%CI 1.3-22.9, p=0.022)] and secondary endpoint-a [3.2 (95%CI 1.1-9.6, p=0.040)] occurrence. Conclusions. These data show an increase of new CVD events in the untreated group. Despite the study limitations, SBI seems to be a negative prognostic factor and ASA preventive treatment might improve SBI prognosis. EU Clinical trial is registered with EudraCT Number: 2005-000996-16; Sponsor Protocol Number: 694/30.06.04.
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spelling doaj-art-88ad19b03ffa4a6d947f701793bece882025-02-03T01:00:32ZengWileyStroke Research and Treatment2090-81052042-00562018-01-01201810.1155/2018/75324037532403Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence StudyIlaria Maestrini0Marta Altieri1Laura Di Clemente2Edoardo Vicenzini3Patrizia Pantano4Eytan Raz5Mauro Silvestrini6Leandro Provinciali7Isabella Paolino8Carmine Marini9Matteo Di Giuseppe10Tommasina Russo11Francesco Federico12Cristiana Coppola13Maria Pia Prontera14Domenico Maria Mezzapesa15Vincenzo Lucivero16Lucilla Parnetti17Paola Sarchielli18Maria Peducci19Domenico Inzitari20Giovanna Carlucci21Carlo Serrati22Carla Zat23Anna Cavallini24Alessandra Persico25Giuseppe Micieli26Stefano Bastianello27Vittorio Di Piero28Department of Human Neuroscience, “Sapienza” University of Rome, Rome, ItalyDepartment of Human Neuroscience, “Sapienza” University of Rome, Rome, ItalyDepartment of Human Neuroscience, “Sapienza” University of Rome, Rome, ItalyDepartment of Human Neuroscience, “Sapienza” University of Rome, Rome, ItalyDepartment of Human Neuroscience, “Sapienza” University of Rome, Rome, ItalyDepartment of Human Neuroscience, “Sapienza” University of Rome, Rome, ItalyNeurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, ItalyNeurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, ItalyNeurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, ItalyDepartment of Internal Medicine and Public Health, University of L’Aquila, L’Aquila, ItalyDepartment of Internal Medicine and Public Health, University of L’Aquila, L’Aquila, ItalyDepartment of Internal Medicine and Public Health, University of L’Aquila, L’Aquila, ItalyDepartment of Neurology and Psychiatrics, University of Bari, Bari, ItalyDepartment of Neurology and Psychiatrics, University of Bari, Bari, ItalyDepartment of Neurology and Psychiatrics, University of Bari, Bari, ItalyDepartment of Neurology and Psychiatrics, University of Bari, Bari, ItalyDepartment of Neurology and Psychiatrics, University of Bari, Bari, ItalyNeurologic Clinic, Department of Medical and Surgical Specialties and Public Health, University of Perugia, Perugia, ItalyNeurologic Clinic, Department of Medical and Surgical Specialties and Public Health, University of Perugia, Perugia, ItalyNeurologic Clinic, Department of Medical and Surgical Specialties and Public Health, University of Perugia, Perugia, ItalyDepartment of NEUROFARBA, University of Florence, Florence, ItalyDepartment of NEUROFARBA, University of Florence, Florence, ItalyDepartment of Neurology, IRCCS San Martino Hospital-IST, Genoa, ItalyNeurological Division, Ospedale Civile di Imperia, Imperia, ItalyDepartment of Cerebrovascular Diseases, Fondazione “Istituto Neurologico C. Mondino”, Pavia, ItalyDepartment of Cerebrovascular Diseases, Fondazione “Istituto Neurologico C. Mondino”, Pavia, ItalyDepartment of Cerebrovascular Diseases, Fondazione “Istituto Neurologico C. Mondino”, Pavia, ItalyDepartment of Brain and Behavioural Sciences, University of Pavia, Pavia, ItalyDepartment of Human Neuroscience, “Sapienza” University of Rome, Rome, ItalyBackground. We investigated low-dose aspirin (ASA) efficacy and safety in subjects with silent brain infarcts (SBIs) in preventing new cerebrovascular (CVD) events as well as cognitive impairment. Methods. We included subjects aged ≥45 years, with at least one SBI and no previous CVD. Subjects were followed up to 4 years assessing CVD and SBI incidence as primary endpoint and as secondary endpoints: (a) cardiovascular and adverse events and (b) cognitive impairment. Results. Thirty-six subjects received ASA while 47 were untreated. Primary endpoint occurred in 9 controls (19.1%) versus 2 (5.6%) in the ASA group (p=0.10). Secondary endpoints did not differ in the two groups. Only baseline leukoaraiosis predicts primary [OR 5.4 (95%CI 1.3-22.9, p=0.022)] and secondary endpoint-a [3.2 (95%CI 1.1-9.6, p=0.040)] occurrence. Conclusions. These data show an increase of new CVD events in the untreated group. Despite the study limitations, SBI seems to be a negative prognostic factor and ASA preventive treatment might improve SBI prognosis. EU Clinical trial is registered with EudraCT Number: 2005-000996-16; Sponsor Protocol Number: 694/30.06.04.http://dx.doi.org/10.1155/2018/7532403
spellingShingle Ilaria Maestrini
Marta Altieri
Laura Di Clemente
Edoardo Vicenzini
Patrizia Pantano
Eytan Raz
Mauro Silvestrini
Leandro Provinciali
Isabella Paolino
Carmine Marini
Matteo Di Giuseppe
Tommasina Russo
Francesco Federico
Cristiana Coppola
Maria Pia Prontera
Domenico Maria Mezzapesa
Vincenzo Lucivero
Lucilla Parnetti
Paola Sarchielli
Maria Peducci
Domenico Inzitari
Giovanna Carlucci
Carlo Serrati
Carla Zat
Anna Cavallini
Alessandra Persico
Giuseppe Micieli
Stefano Bastianello
Vittorio Di Piero
Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study
Stroke Research and Treatment
title Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study
title_full Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study
title_fullStr Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study
title_full_unstemmed Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study
title_short Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study
title_sort longitudinal study on low dose aspirin versus placebo administration in silent brain infarcts the silence study
url http://dx.doi.org/10.1155/2018/7532403
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