Open Access
CC BY 4.0 · Arq Neuropsiquiatr 2025; 83(10): s00451812028
DOI: 10.1055/s-0045-1812028
Original Article

Pilot randomized controlled trial of acetylsalicylic acid to reduce cerebral microembolism in Chagas heart failure

Autoren

  • Renan Carvalho Castello-Branco

    1   Universidade Federal da Bahia, Hospital Universitario Professor Edgard Santos, Pós-Graduação em Ciências da Saúde, Salvador BA, Brazil.
  • Cárita Victoria Carvalho de Santana

    1   Universidade Federal da Bahia, Hospital Universitario Professor Edgard Santos, Pós-Graduação em Ciências da Saúde, Salvador BA, Brazil.
  • Victor L. P. P. Botelho

    1   Universidade Federal da Bahia, Hospital Universitario Professor Edgard Santos, Pós-Graduação em Ciências da Saúde, Salvador BA, Brazil.
  • Paulo R. S. P. deSousa

    1   Universidade Federal da Bahia, Hospital Universitario Professor Edgard Santos, Pós-Graduação em Ciências da Saúde, Salvador BA, Brazil.
  • Maria C.P. Nunes

    2   Universidade Federal de Minas Gerais, Faculdade de Medicina, Ambulatório de Insuficiência Cardíaca, Belo Horizonte MG, Brazil.
  • Karen L. Furie

    3   Brown University, Neurology Service, Providence RI, United States.
  • Jamary Oliveira-Filho

    1   Universidade Federal da Bahia, Hospital Universitario Professor Edgard Santos, Pós-Graduação em Ciências da Saúde, Salvador BA, Brazil.

Abstract

Background

Chagas disease is an important cause of heart failure (HF) and stroke, affecting over 6 million people. High-intensity transient signals (HITS) are detected on transcranial Doppler (TCD) in patients with Chagas disease, but the effect of antithrombotic treatment on HITS is unknown.

Objective

To evaluate whether acetylsalicylic acid (ASA) reduces the frequency and number of HITS in patients with Chagasic HF.

Methods

Proof-of-principle pilot prospective, randomized, open, blinded endpoint (PROBE) clinical trial, in which patients with both Chagas and HITS were randomized 2:1 to ASA 300 mg for 7 days and standard HF treatment or standard HF treatment alone (control group). The primary outcome was the proportion of HITS after one week, analyzed using the Chi-squared test.

Results

A total of 373 patients with HF were evaluated, with HITS occurring in 22/190 (12%) Chagasic patients and in 16/183 (8%) non-Chagasic patients (p = 0.531). Twelve of the 22 (54%) Chagasic patients were randomized to treatment with (n = 8) or without ASA (n = 4). Two patients in the control group (50%) persisted with HITS after 7 days of treatment, compared to none in the ASA group, p = 0.028. The median number of HITS decreased from 3.5 to 0 with ASA (p = 0.012) and 4.0 to 0.5 in the control group (p = 0.095), with no significant between-group difference (p = 0.262). No adverse events were reported.

Conclusion

In the present pilot clinical trial, ASA reduced the proportion of HITS in patients with Chagas disease HF.

Authors' Contributions

Conceptualization: RCCB, MCPN, KLF, JOF; Data curation: RCCB, CVCS, VLPPB, PRSPS; Formal analysis: RCCB, CVCS, MCPN, KLF, JOF; Funding acquisition: RCCB, JOF; Investigation: RCCB, CVCS, VLPPB, PRSPS, MCPN, KLF, JOF; Project administration: RCCB, CVCS, MCPN, KLF, JOF; Validation: RCCB, CVCS, MCPN, KLF, JOF; Visualization: RCCB, CVCS, VLPPB, PRSPS, MCPN, KLF, JOF; Writing – original draft: RCCB; Writing – review & editing: RCCB, CVCS, JOF; Supervision: RCCB, JOF; Resources: RCCB, JOF.


Data Availability Statement

The anonymized data not published within this article will be made available by request from any qualified investigator.


Editor-in-Chief: Ayrton Roberto Massaro (https://orcid.org/0000-0002-0487-5299).


Associate Editor: Octávio Marques Pontes Neto (0000-0003-0317-843X).




Publikationsverlauf

Eingereicht: 08. März 2025

Angenommen: 27. Juli 2025

Artikel online veröffentlicht:
27. Oktober 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit (https://creativecommons.org/licenses/by/4.0/)

Thieme Revinter Publicações Ltda.
Rua Rego Freitas, 175, loja 1, República, São Paulo, SP, CEP 01220-010, Brazil

Bibliographical Record
Renan Carvalho Castello-Branco, Cárita Victoria Carvalho de Santana, Victor L. P. P. Botelho, Paulo R. S. P. deSousa, Maria C.P. Nunes, Karen L. Furie, Jamary Oliveira-Filho. Pilot randomized controlled trial of acetylsalicylic acid to reduce cerebral microembolism in Chagas heart failure. Arq Neuropsiquiatr 2025; 83: s00451812028.
DOI: 10.1055/s-0045-1812028