Metoprolol and Trimetazidine for Coronary Heart Disease With Angina

NCT ID: NCT07074834

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-12-31

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.

Detailed 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.

Conditions

Coronary Heart Disease (CHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Treatment Group

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

Group Type: EXPERIMENTAL

Metoprolol Succinate Sustained-Release Tablets

Intervention Type: DRUG

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

Trimetazidine

Intervention Type: DRUG

Oral administration. Dose was one tablet twice daily.

Routine Drug Therapy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Routine Drug Therapy

Intervention Type: 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).

Interventions

Metoprolol Succinate Sustained-Release Tablets

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

Intervention Type: DRUG

Trimetazidine

Oral administration. Dose was one tablet twice daily.

Intervention Type: DRUG

Routine Drug Therapy

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 46 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiyan City Renmin Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Qunxiong Fan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, China

Countries

China

Other Identifiers

syrmyy2020-068

Identifier Type: -

Identifier Source: org_study_id