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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Treatment Group | Experimental | Patients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months. |
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| Active Comparator: Control Group | Active Comparator | Patients were randomized to receive routine drug therapy for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol Succinate Sustained-Release Tablets | Drug | Oral administration. Dose was 23.75 mg once daily for the first two weeks, then increased to 47.50 mg once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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%. | At 3 months |
| Change in Frequency of Angina Attacks | The mean number of angina attacks per week was recorded and compared between groups. | 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. | From Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From Baseline to 3 months |
| Change in Duration of Angina Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital, Hubei University of Medicine | Shiyan | Hubei | 442000 | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Trimetazidine | Drug | Oral administration. Dose was one tablet twice daily. |
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| Routine Drug Therapy | Drug | 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). |
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The mean duration of angina attacks was recorded and compared.
| 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. | From Baseline to 3 months |
| Change in Left Ventricular End-Diastolic Diameter (LVEDD) | LVEDD was measured by color Doppler ultrasound to assess cardiac remodeling. | From Baseline to 3 months |
| Change in Left Ventricular End-Systolic Diameter (LVESD) | LVESD was measured by color Doppler ultrasound to assess cardiac remodeling. | From Baseline to 3 months |
| Change in Serum Interleukin-18 (IL-18) levels | Serum IL-18 levels were measured using ELISA. | 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. | Over 3 months |