Effectiveness of Metoprolol Succinate Combined With Trimetazidine in Reducing Inflammatory Biomarkers and Improving Clinical Outcomes in Coronary Heart Disease With Angina Pectoris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Clinical Efficacy Rate
研究概览
简要总结
This is a prospective, randomized study to evaluate the effectiveness and safety of combining metoprolol succinate with trimetazidine compared to standard therapy for patients with coronary heart disease (CHD) and angina pectoris. The study aims to assess the effects of the combination therapy on inflammatory biomarkers, clinical efficacy, angina symptoms, and left ventricular function over a 3-month treatment-period.
详细描述
Coronary heart disease (CHD) with angina pectoris is a significant cause of morbidity and mortality. While standard treatments like β-blockers (e.g., metoprolol succinate) are effective, many patients continue to experience symptoms. Inflammation is known to play a crucial role in the pathophysiology of CHD. This study was designed to investigate whether the addition of trimetazidine, a myocardial anti-ischemic agent that improves cellular energy metabolism, to standard metoprolol succinate therapy could offer superior benefits. This prospective study enrolled and randomized 102 patients with CHD and angina into two groups: a control group receiving routine drug therapy and a treatment group receiving routine therapy plus metoprolol succinate and trimetazidine. The primary objective was to compare the therapeutic efficacy, changes in angina attack frequency and severity, improvements in left ventricular function, and reductions in key inflammatory markers (IL-1β, TNF-α, hs-CRP, IL-18) between the two groups after 3 months of treatment. The study aims to provide evidence for this combination therapy as a safe and effective option for managing CHD with angina pectoris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 46 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CHD and angina pectoris based on CAD and angina pectoris guidelines.
- •History of previous myocardial infarction, confirmed by coronary angiography or coronary computed tomography angiography, with at least one coronary artery stenosis ≥50%.
- •Disease duration over 3 months.
- •Frequency of angina attacks in the past week was ≥3 times, with a severity grade of I, II, or III.
- •All patients signed an informed consent form.
排除标准
- •Patients with mental disorders, drug allergies, acute myocardial infarction, electrolyte imbalances, important organ dysfunction, or cardiomyopathy.
- •Patients with severe immune or infectious diseases.
- •Those with stable symptoms or no symptoms after acute coronary syndrome.
- •Patients with severe arrhythmia, uncontrolled hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg), pacemaker, or aortic dissection.
- •Pregnant or lactating women.
- •Patients requiring revascularization (e.g., multi-vessel disease, left main disease, or ischemic areas >10% of the left ventricle).
- •Patients who participated in other clinical trials within the past month.
研究组 & 干预措施
Experimental: Treatment Group
Patients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months.
干预措施: Metoprolol Succinate Sustained-Release Tablets (Drug)
Experimental: Treatment Group
Patients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months.
干预措施: Trimetazidine (Drug)
Experimental: Treatment Group
Patients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months.
干预措施: Routine Drug Therapy (Drug)
Active Comparator: Control Group
Patients were randomized to receive routine drug therapy for 3 months.
干预措施: Routine Drug Therapy (Drug)
结局指标
主要结局
Change in Clinical Efficacy Rate
时间窗: At 3 months
Clinical efficacy was assessed based on symptom changes and reduction in angina attacks. Efficacy was categorized as "Marked effect" (symptoms nearly controlled, attacks decreased \>80%), "Effective" (symptoms partially improved, attacks decreased 50-80%), or "Ineffective". The total effective rate was calculated as (Marked effect + Effective) / Total cases × 100%.
Change in Frequency of Angina Attacks
时间窗: From Baseline to 3 months
The mean number of angina attacks per week was recorded and compared between groups.
Change in Serum Inflammatory Markers
时间窗: From Baseline to 3 months
Changes in serum levels of Interleukin-1 beta (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) were measured using ELISA and immune transmission nephelometry.
次要结局
- Change in Angina Pain Score(From Baseline to 3 months)
- Change in Duration of Angina Episodes(From Baseline to 3 months)
- Change in Left Ventricular Ejection Fraction (LVEF)(From Baseline to 3 months)
- Change in Left Ventricular End-Diastolic Diameter (LVEDD)(From Baseline to 3 months)
- Change in Left Ventricular End-Systolic Diameter (LVESD)(From Baseline to 3 months)
- Change in Serum Interleukin-18 (IL-18) levels(From Baseline to 3 months)
- Incidence of Adverse Reactions(Over 3 months)
研究者
Qunxiong Fan
Principal investigator
Shiyan City Renmin Hospital