Abstract
BackgroundTrimetazidine is a metabolic anti-ischemic agent, which increases the tolerance of cardiomyocytes to ischemia. However, few studies have explored the effect of trimetazidine on ventricular remodeling in coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with left ventricular hypertrophy (LVH).MethodsIt is a randomized, placebo-controlled trial, and we propose to recruit one hundred and twenty-four CAD patients undergoing PCI with LVH during a 12-month period. They will be randomized to receive either trimetazidine (35 mg twice a day) or placebo in the following 12 months after PCI. Blood tests, echocardiography, symptom of angina and major adverse cardiovascular events (MACEs) will be collected at follow-up visit at 3 and 12 months. The primary end point will be the left ventricular remodeling measured by left ventricular mass index (LVMI) at 3- and 12-month follow-up compared with the baseline. The secondary end points will be the symptom of angina assessed by Seattle Angina Questionnaire, myocardial ischemia measured by 6-min walk test and exercise electrocardiography test, as well as MACEs (defined as a composite of death, myocardial infarction, stroke, recurrent angina, re-hospitalization, change of viable myocardium).DiscussionThis study aims to demonstrate the effect of trimetazidine on left ventricular remodeling and myocardial ischemia in CAD patients undergoing PCI with LVH. Trimetazidine treatment is likely to improve the left ventricular remodeling, symptoms of angina and myocardial ischemia. It might also reduce the risk of MACEs in CAD patients undergoing PCI with LVH.Trial registrationhttp://www.chictr.org.cn, Chinese Clinical Trial Registry (ChiCTR1800017876). Registered on 19 Aug 2018.
Highlights
Trimetazidine is a metabolic anti-ischemic agent, which increases the tolerance of cardiomyocytes to ischemia
Statistical considerations Sample size According to previous study [20], we hypothesized trimetazidine group has an effective rate of 70% to improve the left ventricular remodeling by reducing left ventricular mass index (LVMI) and placebo group has 40%, 56 patients in each group are necessary to offer 90% power at 0.05 significant level according to 1:1 ratio of random grouping
The result of the study will confirm whether trimetazidine improves ventricular remodeling, angina and myocardial ischemia
Summary
Trimetazidine is a metabolic anti-ischemic agent, which increases the tolerance of cardiomyocytes to ischemia. Few studies have explored the effect of trimetazidine on ventricular remodeling in coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with left ventricular hypertrophy (LVH). PCI has become one of the leading treatment methods for coronary heart diseases, microcirculation disturbance and cardiac metabolic disorders caused by LVH still cannot be effectively relieved. Trimetazidine optimizes the energy utilization of myocardial cells and maintains a proper energy supply during ischemia [13] It protects the heart by inhibiting oxidative stress [14], scavenging oxygen free radicals [15, 16], improving lipid metabolism and mitochondrial function [14, 17], and reducing ionic imbalance during ischemia and reperfusion [18]. Its long-term effect on left ventricular remodeling in CAD patients undergoing PCI is still unclear
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