Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia

Study Overview
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Brief Summary
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Dyslipidemia is an independent risk factor for cardiovascular events. Statins have become the cornerstone for the prevention and treatment of atherosclerotic vascular diseases. However, after the comprehensive control of the traditional risk factors, including unhealthy lifestyle, hypercholesterolemia, hypertension, hyperglycemia and obesity, there is still a high risk of residual cardiovascular disease in patients with dyslipidemia. Triglyceride elevation is the most common type of dyslipidemia and constitutes an important component of cardiovascular residual risk. The geraniol has a variety of pharmacological effects, such as anti-inflammatory, antioxidant, regulating cell apoptosis. Recent studies have confirmed that geraniol plays an important role in regulating glucose and lipid metabolism, and may have a synergistic role with statins. Gefarnate Tablets is a kind of anti-ulcer and gastritis treatment. It can increase the defense ability of gastric mucosa by improving the prostaglandin level and the concentration of amino hexose in the gastric mucosa. Geraniol is the main components of Gefarnate Tablets. In the previous study, the investigators found that geraniol induced autophagy through the SIRT1-AMPK-mTOR pathway and accelerated the degradation of triglycerides in liver cells, thus reducing the level of triglyceride in the serum of high fat diet mice. 6 patients with hyperlipidemia were received Gefarnate Tablets (100mg/ times, 3 times per day). A month later, the levels of serum triglyceride, total cholesterol, and low density lipoprotein cholesterol were decreased significantly. However, the above results need to be confirmed by the larger clinical research. Therefore, the aim of this study is to evaluate the effect of Gefarnate Tablets on blood lipid levels in patients with hypertriglyceridemia and coronary heart disease treated with statins, provide more options for the treatment of lipid lowering treatment, reduce the risk of cardiovascular remnant, and improve the long-term prognosis of the coronary heart disease patients with residual hypertriglyceridemia.

Official Title
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Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Gefarnate
* Drug: Statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary artery disease Treatment with statins for more than 1 month Plasma triglyceride level more than 1.7mmol/L Exclusion Criteria: Atherosclerotic cardiovascular disease (ASCVD) patients with high risk Patients with active liver disease or unexplained elevated levels of aminotransferase Patients with prostatic hypertrophy or those with prostaglandin drugs such as glaucoma Creatinine clearance < 30ml/min an allergy to any component of Gefarnate Tablets or statin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Statin group<br>Receiving statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) only for 1 month. | Drug: Statin<br>* Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.<br>|
| Experimental: Gefarnate group<br>Combined treatment with statins (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) and gefarnate (100 mg, three times daily, oral) for 1 month. | Drug: Gefarnate<br>* Gefarnate (100 mg, three times daily, oral) treatment for 1 month.<br>Drug: Statin<br>* Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride change from baseline | Triglyceride change from baseline | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol and low density lipoprotein cholesterol changes from baseline | Total cholesterol and low density lipoprotein cholesterol changes from baseline | 1 month |