Renmin Hospital, Hubei University of Medicine
Shiyan, Hubei, 442000, China
NCT Number: NCT07074834
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.
Looking for future studies?
Notify Me46 year–76 year
All sexes
Interventional
Not applicable
Shiyan, Hubei, 442000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administration. Dose was 23.75 mg once daily for the first two weeks, then increased to 47.50 mg once daily.
Oral administration. Dose was one tablet twice daily.
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).
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%.
Time frame: From Baseline to 3 months
The mean number of angina attacks per week was recorded and compared between groups.
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.
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).
Time frame: From Baseline to 3 months
The mean duration of angina attacks was recorded and compared.
Time frame: From Baseline to 3 months
LVEF was measured by color Doppler ultrasound to assess left ventricular systolic function.
Time frame: From Baseline to 3 months
LVEDD was measured by color Doppler ultrasound to assess cardiac remodeling.
Time frame: From Baseline to 3 months
LVESD was measured by color Doppler ultrasound to assess cardiac remodeling.
Time frame: From Baseline to 3 months
Serum IL-18 levels were measured using ELISA.
Time frame: Over 3 months
The number and percentage of patients experiencing adverse reactions, including gastrointestinal abnormalities, arrhythmias, or hypotension, were recorded.
Shiyan City Renmin Hospital
Other Gov
Effectiveness of Metoprolol Succinate Combined With Trimetazidine in Reducing Inflammatory Biomarkers and Improving Clinical Outcomes in Coronary Heart Disease With Angina Pectoris
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.
Published trials that share one or more normalized conditions with this study.
NCT03872401
Cardiovascular Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Athens, Alabama, United States
View Trial DetailsNCT07589036
Cardiovascular Diseases, Coronary Disease
Fuzhou, Fujian, China
View Trial DetailsNCT06941597
Cardiovascular Abnormalities, Cardiovascular Diseases
Brest, France
View Trial DetailsNCT07062432
Cardiovascular Diseases, Coronary Disease
Shijiazhuang, Hebei, China
View Trial Details