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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03610321
• Other study ID #: 201867
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypertriglyceridemia
• Myocardial Ischemia

Intervention

Drug:
• Gefarnate
Gefarnate (100 mg, three times daily, oral) treatment for 1 month.
• Statin
Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.

Locations

Country	Name	City	State
China	the first affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride change from baseline	Triglyceride change from baseline	1 month
Secondary	Total cholesterol and low density lipoprotein cholesterol changes from baseline	Total cholesterol and low density lipoprotein cholesterol changes from baseline	1 month