An interventional study of Metoprolol Succinate Sustained-Release Tablets and Trimetazidine in Coronary Heart Disease (CHD), sponsored by Shiyan City Renmin Hospital. Completed at 1 site in China. Open to participants aged 46 Years to 76 Years. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Shiyan City Renmin Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.
This study's enrollment of 102 is below the median of 124 across 1,583 interventional studies indexed under Coronary Disease.
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Exclusion Criteria:
Patients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months.
Drug: Metoprolol Succinate Sustained-Release Tablets · Drug: Trimetazidine · Drug: Routine Drug Therapy
Patients were randomized to receive routine drug therapy for 3 months.
Drug: Routine Drug Therapy
Oral administration. Dose was 23.75 mg once daily for the first two weeks, then increased to 47.50 mg once daily.
Oral administration. Dose was one tablet twice daily.
Included oral nitroglycerin tablets (0.5 mg twice daily), aspirin enteric-coated tablets (0.1 g once daily), and rosuvastatin calcium tablets (10 mg three times daily).
Change in Clinical Efficacy Rate
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%.
Time frame: At 3 months
Change in Frequency of Angina Attacks
The mean number of angina attacks per week was recorded and compared between groups.
Time frame: From Baseline to 3 months
Change in Serum Inflammatory Markers
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.
Time frame: From Baseline to 3 months
Change in Angina Pain Score
Pain severity was assessed using the Visual Analog Scale (VAS) with a score from 0 (no pain) to 10 (most severe pain).
Time frame: From Baseline to 3 months
Change in Duration of Angina Episodes
The mean duration of angina attacks was recorded and compared.
Time frame: From Baseline to 3 months
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF was measured by color Doppler ultrasound to assess left ventricular systolic function.
Time frame: From Baseline to 3 months
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
LVEDD was measured by color Doppler ultrasound to assess cardiac remodeling.
Time frame: From Baseline to 3 months
Change in Left Ventricular End-Systolic Diameter (LVESD)
LVESD was measured by color Doppler ultrasound to assess cardiac remodeling.
Time frame: From Baseline to 3 months
Change in Serum Interleukin-18 (IL-18) levels
Serum IL-18 levels were measured using ELISA.
Time frame: From Baseline to 3 months
Incidence of Adverse Reactions
The number and percentage of patients experiencing adverse reactions, including gastrointestinal abnormalities, arrhythmias, or hypotension, were recorded.
Time frame: Over 3 months
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Shiyan City Renmin Hospital