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

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.