Coronary Artery DiseasePhase 2/3NCT03610321
Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia
A Phase 2/3 study testing Gefarnate and Statin in people with Coronary Artery Disease, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Gefarnate and Statin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease
- Treatment with statins for more than 1 month
- Plasma triglyceride level more than 1.7mmol/L
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the first affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
About this study
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
- Being tested
- Gefarnate, Statin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefarnateDrug
Gefarnate (100 mg, three times daily, oral) treatment for 1 month.
StatinDrug
Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Statin group | Active comparator | Receiving statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) only for 1 month. Receives: 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. Receives: Drug: Gefarnate; Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride change from baseline
Triglyceride change from baseline
Measured: 1 month
Secondary outcomes (1)
Total cholesterol and low density lipoprotein cholesterol changes from baseline
Total cholesterol and low density lipoprotein cholesterol changes from baseline
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Sep 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610321
- Sponsor's protocol ID
- 201867
- Status last verified
- Jun 2020
- First submitted
- 26 Jul 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT03610321
- Acronym / sponsor ID
- 201867
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin group | Active comparator | Drug: StatinReceiving statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) only for 1 month. |
| Gefarnate group | Experimental | Drug: Gefarnate, Drug: StatinCombined treatment with statins (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) and gefarnate (100 mg, three times daily, oral) for 1 month. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Coronary artery disease
- Treatment with statins for more than 1 month
- Plasma triglyceride level more than 1.7mmol/L
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefarnateGefarnate (100 mg, three times daily, oral) treatment for 1 month. | Drug | Gefarnate group |
| StatinStatin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month. | Drug | Gefarnate group, Statin group |
Primary outcome
Triglyceride change from baseline
Time frame: 1 month
Triglyceride change from baseline
1 secondary outcome
Total cholesterol and low density lipoprotein cholesterol changes from baseline
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gefarnate and Statin in people with Coronary Artery Disease, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride change from baseline (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.