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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Statin; Drug: Gefarnate

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The First Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Statin group; Receiving statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) only for 1 month.	Drug: Statin; Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.
EXPERIMENTAL: Gefarnate group; 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: Statin; Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.; Drug: Gefarnate; Gefarnate (100 mg, three times daily, oral) treatment for 1 month.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypertriglyceridemia; Gastrointestinal Agents; Anti-Ulcer Agents; Gefarnate
• Other Study ID Numbers: 201867

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No