Efficacy and safety of Naoxintong capsule for secondary prevention after reperfused acute myocardial infarction: a randomized, double-blind, placebo-controlled, multicenter trial.

BACKGROUND

. Despite advances in reperfusion therapy, the incidence and mortality risk of heart failure (HF) remain high among patients with acute myocardial infarction (AMI). Naoxintong (NXT), a well-characterized polyherbal formulation derived from traditional Chinese medicine, has shown potential benefits in preclinical and small-scale clinical studies, but its efficacy has not been tested in a large-scale randomized controlled trial.

AIM: . To rigorously evaluate the efficacy and safety of NXT in reducing HF and major adverse cardiovascular events (MACEs) among AMI patients after reperfusion therapy.

STUDY

DESIGN

. A prospective, multicenter, randomized, double-blind, placebo-controlled, superiority trial.

METHODS

. Eligible post-reperfusion AMI patients from 21 hospitals in China were randomly assigned to receive either NXT (4 capsules, three times daily) or a matching placebo for 3 months, in addition to guideline-directed medical therapy (GDMT), with follow-up through 12 months. The primary endpoint was the incidence of new-onset HF within 12 months after randomization. Participants, clinicians, and outcome assessors were blinded to treatment allocation throughout the study period.

RESULTS

. A total of 379 patients were included in the primary analysis (mean age 61.6 years; 78.1% male). The incidence of HF was significantly lower in the NXT group than in the placebo group (5.98%vs. 14.06%; HR 0.41, 95% CI 0.21-0.81; p = 0.01). The incidence of MACEs was also reduced with NXT (7.97%vs. 14.84%; HR 0.52, 95% CI 0.28-0.98; p = 0.04). The rates of serious adverse events (7.97%vs. 14.84%; p = 0.042) and any adverse events (7.97%vs. 21.09%; p < 0.001) were lower in the NXT group. No other significant between-group differences were observed for secondary outcomes or adverse event subtypes.

CONCLUSION

. NXT, administered in addition to standard GDMT, significantly reduced the 12-month risk of HF and MACEs in reperfused AMI patients, with a favourable safety profile. These findings support NXT as a promising complementary strategy for secondary prevention after AMI.