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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gefarnate
Statin
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the first affiliated hospital of Harbin medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Statin group

Gefarnate group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Triglyceride change from baseline
Triglyceride change from baseline

Secondary Outcome Measures

Total cholesterol and low density lipoprotein cholesterol changes from baseline
Total cholesterol and low density lipoprotein cholesterol changes from baseline

Full Information

First Posted
July 26, 2018
Last Updated
July 28, 2020
Sponsor
First Affiliated Hospital of Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03610321
Brief Title
Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia
Official Title
Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Statin group
Arm Type
Active Comparator
Arm Description
Receiving statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) only for 1 month.
Arm Title
Gefarnate group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gefarnate
Intervention Description
Gefarnate (100 mg, three times daily, oral) treatment for 1 month.
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.
Primary Outcome Measure Information:
Title
Triglyceride change from baseline
Description
Triglyceride change from baseline
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Total cholesterol and low density lipoprotein cholesterol changes from baseline
Description
Total cholesterol and low density lipoprotein cholesterol changes from baseline
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
the first affiliated hospital of Harbin medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China

12. IPD Sharing Statement

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

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