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

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 PeducciDomenico Inzitari, Giovanna Carlucci, Carlo Serrati, Carla Zat, Anna Cavallini, Alessandra Persico, Giuseppe Micieli, Stefano Bastianello, Vittorio Di Piero

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)7532403
JournalStroke Research and Treatment
Publication statusPublished - Oct 3 2018


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