Metoprolol and Trimetazidine for Coronary Heart Disease With Angina

Shiyan City Renmin Hospital

Status: Completed

Conditions: Coronary Heart Disease (CHD)

Treatments: Drug: Routine Drug Therapy; Drug: Metoprolol Succinate Sustained-Release Tablets; Drug: Trimetazidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07074834

syrmyy2020-068

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 patients

Sex: All

Ages: 46 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Experimental: Treatment Group

Experimental group

Description:

Patients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months.

Treatment:

Drug: Trimetazidine

Drug: Metoprolol Succinate Sustained-Release Tablets

Drug: Routine Drug Therapy

Active Comparator: Control Group

Active Comparator group

Description:

Patients were randomized to receive routine drug therapy for 3 months.

Treatment:

Drug: Routine Drug Therapy