Metoprolol and Trimetazidine for Coronary Heart Disease With Angina

Shiyan City Renmin Hospital102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Coronary Heart Disease (CHD)

Interventions

Metoprolol Succinate Sustained-Release TabletsDRUG

Oral administration. Dose was 23.75 mg once daily for the first two weeks, then increased to 47.50 mg once daily.

TrimetazidineDRUG

Oral administration. Dose was one tablet twice daily.

Routine Drug TherapyDRUG

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).

Eligibility

Sex: ALLMin age: 46 YearsMax age: 76 Years

Medical Language ↔ Plain English

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.

Locations (1)

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, China

Outcomes

Primary Outcomes

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.