HypertriglyceridemiaTRISTANNCT04650152
Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
An observational study of Hypertriglyceridemia and Metabolic Syndrome, run by Abbott at 63 sites in Russia.
Trial summary
This study is a prospective observational program within the frames of which Tricor (fenofibrate) is prescribed to patients with hypertriglyceridemia within a routine procedure as a part of the combination therapy with statins. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertriglyceridemia, Metabolic Syndrome
- What is being tested?
- Tricor (fenofibrate), 145 mg, film-coated tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 63 sitesRussia
- Study dates
- 27 Oct 2020to 12 Nov 2021
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The program will include adult patients with triglycerides > 2,3 mmol/l who are on statins and who are primary prescribed fenofibrate (or fenofibrate treatment break is at least 6 months) in accordance with ordinary physician practice in Russia. The decision to prescribe fenofibrate should be made not on the basis of this protocol but in accordance with the routine clinical practice and must be clearly separated from the decision to include the patient in the program. No additional diagnostic procedures (in addition to standard medical care) should be prescribed. The program included a questionnaire for patients to assess the quality of life.
Who may be able to join
- Men and women ≥ 18 years of age.
- Triglycerides level above 2,3 mmol/l.
- Patients having been prescribed fenofibrate 145 mg for at least 6 months AND who have been taking fenofibrate 145 mg no more than 3 days at the time of enrollment into the study.
- Patient who take statins at the time of enrollment into the study.
- Patients who have signed the informed consent to participate in this program.
Who cannot join
- Patients who took last dose within previous treatment course of fenofibrate less than 3 months ago.
- Statin-intolerant patients.
- Female patients during pregnancy or breastfeeding.
- diabetes mellitus (DM) type 1
- Participation in any other clinical or non-clinical study/program at present or within the latest 30 days.
- Patients with any other clinical states that make him/her ineligible for the program on the study doctor's opinion based on clinical assessment.
Show all 13Show fewer
- Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality).
- Known gallbladder disease.
- Severe chronic kidney disease (creatinine clearance <60 ml/min).
- Chronic or acute pancreatitis.
- Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
- Hypersensitivity to the active substance(s) or to any of the excipients.
- Allergic to peanut or arachis oil or soya lecithin or related products due to risk of hypersensitivity reactions.
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
Russia63 sites
City Polyclinic #14 (branch office)
Barnaul, 656067
Clinical Diagnostic Centre
Bryansk, 241050
Polyclinic #1
Cheboksary, 428027
Diagnostic Centre
Cheboksary, 428034
Polyclinic #1
Chelyabinsk, 454071
Polyclinic
Chelyabinsk, 454091
Polyclinic #1
Irkutsk, 664046
Clinical hospital
Irkutsk, 664049
City Polyclinic #4
Irkutsk, 664058
Medical center
Kaliningrad, 236001
Polyclinic
Kazan', 420059
Polyclinic #2 of Hospital #4
Kemerovo, 650024
Polyclinic
Kemerovo, 650033
City polyclinic 7/ ID 015
Krasnoyarsk, 660021
Dispensary
Krasnoyarsk, 660123
City Polyclinic #23
Moscow, 109431
City Polyclinic # 166 (branch office #2)
Moscow, 115304
City Polyclinic #166 (branch office #3)
Moscow, 115582
Clinical Diagnostic Centre #1 (branch office #4)
Moscow, 117513
City Polyclinic #170 (branch office #2)
Moscow, 117519
Medical center
Moscow, 125414
Polyclinic
Moscow, 127562
Regional hospital
Moscow Region, 141103
City Polyclinic
Moscow Region, 142203
Medical center
Moscow Region, 143985
Medical center
Nizhny Novgorod, 603004
Polyclinic #40
Nizhny Novgorod, 603004
Polyclinic of City Hospital #40
Nizhny Novgorod, 603004
Medical center
Nizhny Novgorod Region, 606440
Polyclinic
Nizhny Tagil, 622049
Polyclinic #4 ГКБ 6
Orenburg, 460000
Medical center
Perm, 614000
Clinical cardiologic dispensary
Perm, 614002
Medical center
Perm, 614012
Medical center
Perm, 614107
City Polyclinic #1 (branch office)
Rostov-on-Don, 344000
City Polyclinic #7
Rostov-on-Don, 344011
City Polyclinic #1
Rostov-on-Don, 344029
Polyclinic of City Hospital #20
Rostov-on-Don, 344091
City Polyclinic #109
Saint Petersburg, 121096
City Polyclinic #109
Saint Petersburg, 192283
City Polyclinic #116
Saint Petersburg, 194356
Medical unit
Saint Petersburg, 195009
City polyclinic #54 / ID 065
Saint Petersburg, 195197
City Polyclinic #71
Saint Petersburg, 196650
City Polyclinic #96
Saint Petersburg, 197022
Polyclinic #34
Saint Petersburg, 197198
City policlinic #3
Samara, 443010
Clinical hospital
Samara, 443067
Medical center
Samara, 443068
City Polyclinic #2
Saratov, 410005
Medical center
Smolensk, 214018
City hospital
Ufa, 450050
Polyclinic of City hospital #21
Ufa, 450071
Polyclinic # 2
Volgograd, 400007
City polyclinic 18 /ID 038
Volgograd, 400075
Polyclinic #30
Volgograd, 400081
Polyclinic #28
Volgograd, 400137
City Polyclinic #7
Voronezh, 394051
City hospital #4
Voronezh, 394077
Polyclinic
Yaroslavl, 150062
Polyclinic
Yekaterinburg, 620014
Medical center
Yekaterinburg, 620026
About this study
Official title: A Prospective Observational Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
This study is a prospective observational program within the frames of which Tricor (fenofibrate) is prescribed to patients with hypertriglyceridemia within a routine procedure as a part of the combination therapy with statins.
Read the detailed description
Metabolic syndrome is a cluster of interrelated risk factors that leads to metabolic dysregulation and atherosclerotic cardiovascular diseases. The increased risk of cardiovascular disease in people with metabolic syndrome has been well established by observational studies and meta-analyses.
Strategies to reduce cardiovascular disease (CVD) risk in primary and secondary prevention focus on the optimization of low-density lipoprotein-cholesterol (LDL-C) levels. As recommended in current guidelines for lowering blood cholesterol, statins in addition to lifestyle modifications remain the first-line therapy to reduce LDL-C in patients at CVD risk. However, despite optimal reduction of LDL-C with statins and, correction of other modifiable risk factors, CVD risk is not eliminated. The source of this residual risk may be due to other atherogenic lipid species such as reduced high-density lipoprotein cholesterol (HDL-C) and/or raised triglycerides (TG) which are only modestly affected by statin therapy.
The use of fibrates in the treatment of dyslipidaemia has changed significantly over recent years.
The potential of fibrate-statin combination treatment is discussed in guidelines and by the medical community. Fenofibrate treatment usually reduce TG by 40-50%, total cholesterol (TC) and LDL-C by 5-20%, as well as small dense LDL by 10-30%.
While fibrates are generally well tolerated, combination with a statin might increase the risk of side effects and potentially that of myopathy. In the ACCORD study, fenofibrate coadministered with simvastatin was neither associated with any increase in the incidence of myopathy over that observed with simvastatin monotherapy in patients with type 2 diabetes, nor pointing out any safety concerns for the coadministration.
In view of the demonstrated lipid benefit and good safety profile, fenofibrate is suitable for add-on therapy with a statin to minimize the CVD residual risk.
This post-marketing observational study is conducted to assess effectiveness of fenofibrate (145 mg daily) as adjuvant therapy to statins administered for 6 months in patients with hypertriglyceridemia and metabolic syndrome.
- Conditions
- Hypertriglyceridemia, Metabolic Syndrome
- Being tested
- Tricor (fenofibrate), 145 mg, film-coated tablet
- Keywords
- Tricor, fenofibrate, metabolic syndrome, hypertriglyceridemia
- Medical subject headings
- Hypertriglyceridemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricor (fenofibrate), 145 mg, film-coated tabletDrug
Also called Tricor
Observational study without intervention. Fenofibrate is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Adult patients with triglycerides > 2,3 mmol/l who are on statins and who are primary prescribed fenofibrate (or fenofibrate treatment break is at least 6 months) in accordance with ordinary physician practice in Russia. Receives: Drug: Tricor (fenofibrate), 145 mg, film-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.
Triglycerides will be represented in mmol/L and change of TG will be displayed as mean difference of TG at Visit 3 vs. Visit 1.
Measured: 6 months
Secondary outcomes (8)
Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
Low-density lipoproteins (LDL) will be represented in mmol/L and change of LDL will be displayed as mean difference of LDL at Visit 3 vs. Visit 1.
Measured: 6months
Change of lipid profile parameters (TC, HDL, non-HDL) at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
Lipid profile includes total cholesterol (TC), high-density lipoproteins (HDL) and non-HDL. The lipid profile parameters will not be combined into 1 value and will be reported as separate values but results will be presented in the same unites of measure (mmol/L). Non-HDL is calculated as total cholesterol minus HDL cholesterol. Change of each lipid profile parameter will be displayed as mean difference of the result at Visit 3 vs. Visit 1.
Measured: 6 months
Change of LDL level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.
Low-density lipoproteins (LDL) will be represented in mmol/L and change of LDL will be displayed as mean difference of LDL at Visit 2 vs. Visit 1.
Measured: 3 months
Change of lipid profile parameters (TC, TG, HDL, non-HDL) at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.
Lipid profile includes total cholesterol (TC), high-density lipoproteins (HDL) and non-HDL. The lipid profile parameters will not be combined into 1 value and will be reported as separate values but results will be presented in the same unites of measure (mmol/L). Non-HDL is calculated as total cholesterol minus HDL cholesterol. Change of each lipid profile parameter will be displayed as mean difference of the result at Visit 2 vs. Visit 1.
Measured: 3 months
Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
Сhange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 3 vs. Visit 1.
Measured: 6 months
Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1
Сhange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 2 vs. Visit 1.
Measured: 3 months
The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.
The 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state. Items in the same scale are averaged together to create the 8 scale scores.
Patients will complete this self-reported questionnaire, containing 36 items, for evaluation of the quality of life after 6 months of treatment.
Measured: 6 months
The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1
The 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state. Items in the same scale are averaged together to create the 8 scale scores.
Patients will complete this self-reported questionnaire, containing 36 items, for evaluation of the quality of life after 3 months of treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start27 Oct 2020
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Solnyshkina, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650152
- Sponsor's protocol ID
- FENO5002
- Acronym
- TRISTAN
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
- ClinicalTrials.gov ID
- NCT04650152
- Acronym / sponsor ID
- TRISTAN / FENO5002
- Conditions
- Hypertriglyceridemia, Metabolic Syndrome
- Keywords
- Tricor, fenofibrate, metabolic syndrome, hypertriglyceridemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 2 Dec 2020 (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.
This study is a prospective observational program within the frames of which Tricor (fenofibrate) is prescribed to patients with hypertriglyceridemia within a routine procedure as a part of the combination therapy with statins.
Detailed description
Metabolic syndrome is a cluster of interrelated risk factors that leads to metabolic dysregulation and atherosclerotic cardiovascular diseases. The increased risk of cardiovascular disease in people with metabolic syndrome has been well established by observational studies and meta-analyses.
Strategies to reduce cardiovascular disease (CVD) risk in primary and secondary prevention focus on the optimization of low-density lipoprotein-cholesterol (LDL-C) levels. As recommended in current guidelines for lowering blood cholesterol, statins in addition to lifestyle modifications remain the first-line therapy to reduce LDL-C in patients at CVD risk. However, despite optimal reduction of LDL-C with statins and, correction of other modifiable risk factors, CVD risk is not eliminated. The source of this residual risk may be due to other atherogenic lipid species such as reduced high-density lipoprotein cholesterol (HDL-C) and/or raised triglycerides (TG) which are only modestly affected by statin therapy.
The use of fibrates in the treatment of dyslipidaemia has changed significantly over recent years.
The potential of fibrate-statin combination treatment is discussed in guidelines and by the medical community. Fenofibrate treatment usually reduce TG by 40-50%, total cholesterol (TC) and LDL-C by 5-20%, as well as small dense LDL by 10-30%.
While fibrates are generally well tolerated, combination with a statin might increase the risk of side effects and potentially that of myopathy. In the ACCORD study, fenofibrate coadministered with simvastatin was neither associated with any increase in the incidence of myopathy over that observed with simvastatin monotherapy in patients with type 2 diabetes, nor pointing out any safety concerns for the coadministration.
In view of the demonstrated lipid benefit and good safety profile, fenofibrate is suitable for add-on therapy with a statin to minimize the CVD residual risk.
This post-marketing observational study is conducted to assess effectiveness of fenofibrate (145 mg daily) as adjuvant therapy to statins administered for 6 months in patients with hypertriglyceridemia and metabolic syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | – | Drug: Tricor (fenofibrate), 145 mg, film-coated tabletAdult patients with triglycerides > 2,3 mmol/l who are on statins and who are primary prescribed fenofibrate (or fenofibrate treatment break is at least 6 months) in accordance with ordinary physician practice in Russia. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The program will include adult patients with triglycerides > 2,3 mmol/l who are on statins and who are primary prescribed fenofibrate (or fenofibrate treatment break is at least 6 months) in accordance with ordinary physician practice in Russia. The decision to prescribe fenofibrate should be made not on the basis of this protocol but in accordance with the routine clinical practice and must be clearly separated from the decision to include the patient in the program. No additional diagnostic procedures (in addition to standard medical care) should be prescribed. The program included a questionnaire for patients to assess the quality of life.
Key inclusion criteria (5 listed)
- Men and women ≥ 18 years of age.
- Triglycerides level above 2,3 mmol/l.
- Patients having been prescribed fenofibrate 145 mg for at least 6 months AND who have been taking fenofibrate 145 mg no more than 3 days at the time of enrollment into the study.
- Patient who take statins at the time of enrollment into the study.
- Patients who have signed the informed consent to participate in this program.
Key exclusion criteria (13 listed)
- Patients who took last dose within previous treatment course of fenofibrate less than 3 months ago.
- Statin-intolerant patients.
- Female patients during pregnancy or breastfeeding.
- diabetes mellitus (DM) type 1
- Participation in any other clinical or non-clinical study/program at present or within the latest 30 days.
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 |
|---|---|---|
| Tricor (fenofibrate), 145 mg, film-coated tabletAlso: TricorObservational study without intervention. Fenofibrate is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication. | Drug | Fenofibrate |
Primary outcome
Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.
Time frame: 6 months
Triglycerides will be represented in mmol/L and change of TG will be displayed as mean difference of TG at Visit 3 vs. Visit 1.
8 secondary outcomes
Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
Time frame: 6months
Change of lipid profile parameters (TC, HDL, non-HDL) at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
Time frame: 6 months
Change of LDL level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.
Time frame: 3 months
Change of lipid profile parameters (TC, TG, HDL, non-HDL) at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.
Time frame: 3 months
Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
Time frame: 6 months
Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1
Time frame: 3 months
The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.
Time frame: 6 months
The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Hypertriglyceridemia
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Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
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RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
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Recruiting
Pemafibrate for Symptomatic ICAS RCT
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A Study to Assess the Safety, Tolerability and Efficacy of ION775
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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.
Irina Solnyshkina study director
Abbott
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertriglyceridemia and Metabolic Syndrome, run by Abbott at 63 sites in Russia.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in Russia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1. (time frame: 6 months). 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 15 Dec 2021.