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NCT Number: NCT07074834

Metoprolol and Trimetazidine for Coronary Heart Disease With Angina

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.

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Key information

Age range

46 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, 442000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Trimetazidine

Drug

Oral administration. Dose was one tablet twice daily.

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).

Primary outcomes

  1. Change in Clinical Efficacy Rate

    Time frame: 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%.

  2. Change in Frequency of Angina Attacks

    Time frame: From Baseline to 3 months

    The mean number of angina attacks per week was recorded and compared between groups.

  3. Change in Serum Inflammatory Markers

    Time frame: 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.

Secondary outcomes

  1. Change in Angina Pain Score

    Time frame: From Baseline to 3 months

    Pain severity was assessed using the Visual Analog Scale (VAS) with a score from 0 (no pain) to 10 (most severe pain).

  2. Change in Duration of Angina Episodes

    Time frame: From Baseline to 3 months

    The mean duration of angina attacks was recorded and compared.

  3. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: From Baseline to 3 months

    LVEF was measured by color Doppler ultrasound to assess left ventricular systolic function.

  4. Change in Left Ventricular End-Diastolic Diameter (LVEDD)

    Time frame: From Baseline to 3 months

    LVEDD was measured by color Doppler ultrasound to assess cardiac remodeling.

  5. Change in Left Ventricular End-Systolic Diameter (LVESD)

    Time frame: From Baseline to 3 months

    LVESD was measured by color Doppler ultrasound to assess cardiac remodeling.

  6. Change in Serum Interleukin-18 (IL-18) levels

    Time frame: From Baseline to 3 months

    Serum IL-18 levels were measured using ELISA.

  7. Incidence of Adverse Reactions

    Time frame: Over 3 months

    The number and percentage of patients experiencing adverse reactions, including gastrointestinal abnormalities, arrhythmias, or hypotension, were recorded.

Sponsors and collaborators

Lead sponsor

Shiyan City Renmin Hospital

Other Gov

Registry information

Official study title

Effectiveness of Metoprolol Succinate Combined With Trimetazidine in Reducing Inflammatory Biomarkers and Improving Clinical Outcomes in Coronary Heart Disease With Angina Pectoris

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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