Metoprolol and Trimetazidine for Coronary Heart Disease With Angina

NCT07074834 | Completed

• 1 other identifier: syrmyy2020-068
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease (CHD)

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Change in Angina Pain Score

  From Baseline to 3 months

• Change in Duration of Angina Episodes

  From Baseline to 3 months

• Change in Left Ventricular Ejection Fraction (LVEF)

  From Baseline to 3 months

• Change in Left Ventricular End-Diastolic Diameter (LVEDD)

  From Baseline to 3 months

• Change in Left Ventricular End-Systolic Diameter (LVESD)

  From Baseline to 3 months

Study Arms (2)

Experimental: Treatment Group

EXPERIMENTAL

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

Active Comparator: Control Group

ACTIVE COMPARATOR

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

Drug: Routine Drug Therapy

Interventions

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.

Experimental: Treatment Group

Trimetazidine DRUG

Oral administration. Dose was one tablet twice daily.

Experimental: Treatment Group

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).

Active Comparator: Control Group; Experimental: Treatment Group

Eligibility Criteria

• Age: 46 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyan City Renmin Hospital: lead

Study Sites (1)

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, 442000, China

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: February 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (1)