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Background:Previous studies of Chinese herbal medicines plus conventional treatment showed some beneficial effects in the treatment of coronary artery disease.Howver,it remains unclear if this treatment method improved clincial outcome as evaluated with cardiovascular events in acuete coronary syndrome after percutaneous coronary intervention. Objective:To evaluate efficacy and safety of Chinese herbal medicines plus conventional treatment on acute coronary syndrome after percutaneous coronary intervention.Design:Prospective,open-label,randomized,controlled trial (chictr.org number:ChiCTR-TRC-00000021).Setting:13 hospitals from 5 provinces in mainland China.Patients:808 adults with acute coronary syndrome after percutaneous coronary intervention.Intervention:Chinese herbal medicines plus conventional treatment (treatment group) or conventional treatment alone (control group).All participants received conventional treatment,but participants in treatment group additionally received Chinese herbal medicines (Xinyue Capsule and Fufang Chuanxiong Capsule),2 capsules orally,3 times daily for 6 months.Measurements:The primary end point was the composite of cardiac death,nonfatal recurrent myocardial infarction or repeat revascularization.The secondary end point was the composite of readmission for acute coronary syndrome,stroke,or congestive heart failure.The safety end point was major bleeding events.Results:The incidence of the primary end point was 2.7% in the treatment group versus 6.2% in the control group (HR,0.43;95%CI,0.21 to 0.87;P=0.015).The incidence of secondary end point was 3.5% in the treatment group versus 8.7% in the control group (HR,0.39;95%CI,0.21 to 0.72;P=0.002).No major bleeding events were found in any participant.Limitations:A double-blind procedure was not used.Conclusions:Treatment with Chinese herbal medicines in combination with conventional treatment further reduced the cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention without increased risk of major bleeding.