ETHNOPHARMACOLOGICAL RELEVANCE: Tongxinluo (TXL), a Chinese patent medicine, is commonly used for secondary prevention of cardiovascular events. AIM OF THE STUDY: To evaluate the efficacy and safety of TXL for secondary prevention after ST-segment elevation myocardial infarction (STEMI). MATERIALS AND METHODS: A search for relevant randomized controlled trials (RCTs) was conducted across seven electronic databases from inception to May 10, 2024. Two independent reviewers conducted trial selection, data collection, and bias assessment. We performed a meta-analysis of efficacy and safety outcomes, and assessed the quality of evidence. RESULTS: Ten RCTs were included, involving 4690 patients with STEMI. Compared to conventional treatments (CTs) alone, TXL combined with CTs reduced the incidence of major adverse cardiac and cerebrovascular events (MACCEs) in patients with STEMI (risk ratio [RR] = 0.61, 95 % confidence interval [CI] 0.51 to 0.73, P <
0.00001). TXL also contributed to improving cardiac function (mean difference [MD] = 4.95, 95 % CI 3.26 to 6.64, P <
0.00001). Furthermore, no statistically significant difference was observed in the incidence of adverse events between the TXL and control groups. The certainty of evidence was evaluated as moderate to low. CONCLUSION: TXL might provide preventive effects against MACCEs for patients with STEMI. However, the efficacy and safety of TXL for secondary prevention in real-world settings require further confirmation through future practice.