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

NCT03610321 | Unknown Phase 2

• 1 other identifier: 201867
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Triglyceride change from baseline

  Triglyceride change from baseline

  1 month

Secondary Outcomes (1)

• Total cholesterol and low density lipoprotein cholesterol changes from baseline

  1 month

Study Arms (2)

Statin group

ACTIVE COMPARATOR

Receiving statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) only for 1 month.

Drug: Statin

Gefarnate group

EXPERIMENTAL

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; Drug: Statin

Interventions

Gefarnate DRUG

Gefarnate (100 mg, three times daily, oral) treatment for 1 month.

Gefarnate group

Statin DRUG

Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.

Gefarnate group; Statin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary artery disease
• Treatment with statins for more than 1 month
• Plasma triglyceride level more than 1.7mmol/L

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

the first affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Gefarnate; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Terpenes; Hydrocarbons; Organic Chemicals; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 1, 2018
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 30, 2020

Record last verified: 2020-06

Locations

CN (1)