Objective To evaluate the efficacy of naoan capsule and aspirin in the prevention of stroke so as to provide theoretical basis for stroke prevention.Methods A total of 4415 individuals at high risk of stroke aged ≥ 40 years,who had exposure to stroke risk factors and hemodynamic abnormalities,were screened from a baseline investigation in a multicenter randomized controlled trial.They were randomly allocated into naoan capsule(n=1656),50 mg aspirin(n=1348)and 75 mg aspirin(n=1411)groups according to villages or communities.Intervention medications were given to the three groups on the basis of general intervention guidelines.The two aspirin groups were given aspririn 50 mg and 75 mg respiratively(Po,Qd),and naoan group was given 1~2 capsules(Po,Bid).The mean intervention medications time was 16 months.The onset of stroke was observed during the follow-up period,and the differences of incidence in all groups were compared.Results The incidence of stroke in the naoan capsule,50 mg aspirin and 75 mg aspirin groups were 6.43,12.92 and 10.37 per 1000 person-years,respectively.The incidence of stroke in the naoan capsule group was significantly lower than that in the 50 mg aspirin group(P0.035)and decreased by 50.2% and 38.0% respectively as compared with the 50 mg and 75 mg aspirin groups.Conclusion The interventional effect of naoan capsule is superior to aspirin in individuals at high risk of stroke.