Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial

Abstract

Improving exercise tolerance is indisputably beneficial for long-term survival in patients treated with percutaneous coronary intervention (PCI). Although previous studies suggested that Yangxinshi tablets effectively improve exercise tolerance in patients with coronary heart disease, the evidence is limited due to the lack of high-quality randomized trials. The Effects of Yangxinshi Tablets on Exercise Tolerance Compared with Trimetazidine in Patients after PCI (HEARTRIP) trial is a multicenter, double-blind, double-dummy, active drug-controlled, randomized trial designed to test if the effects of Yangxinshi tablets on exercise tolerance are non-inferior to those of trimetazidine in patients undergoing PCI. A total of 668 patients who have undergone PCI for the first time and completed a cardiopulmonary exercise test (CPET) will be enrolled and randomly assigned, in a 1:1 ratio, to receive Yangxinshi tablets (3 tablets, 3 times/d) plus trimetazidine-placebo or trimetazidine (20 mg, 3 times/d) plus Yangxinshi-placebo for 24 weeks. The primary endpoint is metabolic equivalent of tasks (METs) measured by CPET at 24 weeks after randomization. The secondary endpoints include comprehensive CPET indicators, incidence of major adverse cardiac and cerebrovascular events, and depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and quality of life (Seattle Angina Questionnaire) scores. This study will appraise current clinical evidence on the beneficial effect of Yangxinshi tablets on improving exercise tolerance after PCI and may substantiate their use as an effective pharmacological option for cardiac rehabilitation patients. The HEARTRIP study protocol received approval from the ethics committee of the General Hospital of Northern Theater Command (Shenyang, China). The procedures set out in this protocol are in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be published following the guidelines of the CONSORT statement in a peer-reviewed scientific journal (Trial registration number: NCT03809273).