Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN) (TRISTAN)

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Hypertriglyceridemia
• Intervention / Treatment: Drug: Tricor (fenofibrate), 145 mg, film-coated tablet

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Russian Federation
  • Barnaul, Russian Federation, 656067
    • City Polyclinic #14 (branch office)
  • Bryansk, Russian Federation, 241050
    • Clinical Diagnostic Centre
  • Cheboksary, Russian Federation, 428027
    • Polyclinic #1
  • Cheboksary, Russian Federation, 428034
    • Diagnostic Centre
  • Chelyabinsk, Russian Federation, 454071
    • Polyclinic #1
  • Chelyabinsk, Russian Federation, 454091
    • Polyclinic
  • Ekaterinburg, Russian Federation, 620014
    • Polyclinic
  • Ekaterinburg, Russian Federation, 620026
    • Medical Center
  • Irkutsk, Russian Federation, 664046
    • Polyclinic #1
  • Irkutsk, Russian Federation, 664049
    • Clinical Hospital
  • Irkutsk, Russian Federation, 664058
    • City Polyclinic #4
  • Kaliningrad, Russian Federation, 236001
    • Medical Center
  • Kazan, Russian Federation, 420059
    • Polyclinic
  • Kemerovo, Russian Federation, 650024
    • Polyclinic #2 of Hospital #4
  • Kemerovo, Russian Federation, 650033
    • Polyclinic
  • Krasnoyarsk, Russian Federation, 660021
    • City polyclinic 7/ ID 015
  • Krasnoyarsk, Russian Federation, 660123
    • Dispensary
  • Moscow, Russian Federation, 109431
    • City Polyclinic #23
  • Moscow, Russian Federation, 115304
    • City Polyclinic # 166 (branch office #2)
  • Moscow, Russian Federation, 115582
    • City Polyclinic #166 (branch office #3)
  • Moscow, Russian Federation, 117513
    • Clinical Diagnostic Centre #1 (branch office #4)
  • Moscow, Russian Federation, 117519
    • City Polyclinic #170 (branch office #2)
  • Moscow, Russian Federation, 125414
    • Medical Center
  • Moscow, Russian Federation, 127562
    • Polyclinic
  • Moscow region, Russian Federation, 141103
    • Regional Hospital
  • Moscow region, Russian Federation, 142203
    • City Polyclinic
  • Moscow region, Russian Federation, 143985
    • Medical Center
  • Nizhniy Tagil, Russian Federation, 622049
    • Polyclinic
  • Nizhny Novgorod, Russian Federation, 603004
    • Medical Center
  • Nizhny Novgorod, Russian Federation, 603004
    • Polyclinic #40
  • Nizhny Novgorod, Russian Federation, 603004
    • Polyclinic of City Hospital #40
  • Nizhny Novgorod region, Russian Federation, 606440
    • Medical Center
  • Orenburg, Russian Federation, 460000
    • Polyclinic #4 ГКБ 6
  • Perm, Russian Federation, 614000
    • Medical Center
  • Perm, Russian Federation, 614002
    • Clinical cardiologic dispensary
  • Perm, Russian Federation, 614012
    • Medical Center
  • Perm, Russian Federation, 614107
    • Medical Center
  • Rostov-on-Don, Russian Federation, 344000
    • City Polyclinic #1 (branch office)
  • Rostov-on-Don, Russian Federation, 344011
    • City Polyclinic #7
  • Rostov-on-Don, Russian Federation, 344029
    • City Polyclinic #1
  • Rostov-on-Don, Russian Federation, 344091
    • Polyclinic of City Hospital #20
  • Saint Petersburg, Russian Federation, 121096
    • City polyclinic #109
  • Saint Petersburg, Russian Federation, 192283
    • City polyclinic #109
  • Saint Petersburg, Russian Federation, 194356
    • City Polyclinic #116
  • Saint Petersburg, Russian Federation, 195009
    • Medical unit
  • Saint Petersburg, Russian Federation, 195197
    • City polyclinic #54 / ID 065
  • Saint Petersburg, Russian Federation, 196650
    • City Polyclinic #71
  • Saint Petersburg, Russian Federation, 197022
    • City Polyclinic #96
  • Saint Petersburg, Russian Federation, 197198
    • Polyclinic #34
  • Samara, Russian Federation, 443010
    • City policlinic #3
  • Samara, Russian Federation, 443067
    • Clinical Hospital
  • Samara, Russian Federation, 443068
    • Medical Center
  • Saratov, Russian Federation, 410005
    • City Polyclinic #2
  • Smolensk, Russian Federation, 214018
    • Medical Center
  • Ufa, Russian Federation, 450050
    • City Hospital
  • Ufa, Russian Federation, 450071
    • Polyclinic of City hospital #21
  • Volgograd, Russian Federation, 400007
    • Polyclinic # 2
  • Volgograd, Russian Federation, 400075
    • City polyclinic 18 /ID 038
  • Volgograd, Russian Federation, 400081
    • Polyclinic #30
  • Volgograd, Russian Federation, 400137
    • Polyclinic #28
  • Voronezh, Russian Federation, 394051
    • City Polyclinic #7
  • Voronezh, Russian Federation, 394077
    • City Hospital #4
  • Yaroslavl, Russian Federation, 150062
    • Polyclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Tricor (fenofibrate), 145 mg, film-coated tablet; 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.; Other Names: Tricor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Irina Solnyshkina, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: hypertriglyceridemia; metabolic syndrome; fenofibrate; Tricor
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Syndrome; Metabolic Syndrome; Hypertriglyceridemia; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: FENO5002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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