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

Completed
Conditions
Hypertriglyceridemia
Metabolic Syndrome
Interventions
Drug: Tricor (fenofibrate), 145 mg, film-coated tablet
Registration Number
NCT04650152
Lead Sponsor
Abbott
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1000
Inclusion Criteria
  • Men and women β‰₯ 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.
Read More
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.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
FenofibrateTricor (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.
Primary Outcome Measures
NameTimeMethod
Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.6 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.

Secondary Outcome Measures
NameTimeMethod
Change of lipid profile parameters (TC, TG, HDL, non-HDL) at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.3 months

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.

Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 13 months

Π‘hange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 2 vs. Visit 1.

Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 16months

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.

Change of lipid profile parameters (TC, HDL, non-HDL) at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 16 months

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.

Change of LDL level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.3 months

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.

Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 16 months

Π‘hange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 3 vs. Visit 1.

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 1.6 months

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.

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 13 months

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.

Trial Locations

Locations (42)

Clinical hospital

πŸ‡·πŸ‡Ί

Samara, Russian Federation

Clinical Diagnostic Centre

πŸ‡·πŸ‡Ί

Bryansk, Russian Federation

Dispensary

πŸ‡·πŸ‡Ί

Krasnoyarsk, Russian Federation

City Polyclinic #23

πŸ‡·πŸ‡Ί

Moscow, Russian Federation

City Polyclinic #1 (branch office)

πŸ‡·πŸ‡Ί

Rostov-on-Don, Russian Federation

City Polyclinic #96

πŸ‡·πŸ‡Ί

Saint Petersburg, Russian Federation

Polyclinic #28

πŸ‡·πŸ‡Ί

Volgograd, Russian Federation

Polyclinic of City hospital #21

πŸ‡·πŸ‡Ί

Ufa, Russian Federation

City Polyclinic #14 (branch office)

πŸ‡·πŸ‡Ί

Barnaul, Russian Federation

Polyclinic #1

πŸ‡·πŸ‡Ί

Irkutsk, Russian Federation

Polyclinic #2 of Hospital #4

πŸ‡·πŸ‡Ί

Kemerovo, Russian Federation

City Polyclinic #4

πŸ‡·πŸ‡Ί

Irkutsk, Russian Federation

Diagnostic Centre

πŸ‡·πŸ‡Ί

Cheboksary, Russian Federation

City polyclinic 7/ ID 015

πŸ‡·πŸ‡Ί

Krasnoyarsk, Russian Federation

Medical center

πŸ‡·πŸ‡Ί

Smolensk, Russian Federation

Polyclinic

πŸ‡·πŸ‡Ί

Yaroslavl, Russian Federation

City Polyclinic #166 (branch office #3)

πŸ‡·πŸ‡Ί

Moscow, Russian Federation

City Polyclinic

πŸ‡·πŸ‡Ί

Moscow region, Russian Federation

City Polyclinic # 166 (branch office #2)

πŸ‡·πŸ‡Ί

Moscow, Russian Federation

City Polyclinic #170 (branch office #2)

πŸ‡·πŸ‡Ί

Moscow, Russian Federation

Regional hospital

πŸ‡·πŸ‡Ί

Moscow region, Russian Federation

Clinical Diagnostic Centre #1 (branch office #4)

πŸ‡·πŸ‡Ί

Moscow, Russian Federation

Polyclinic of City Hospital #40

πŸ‡·πŸ‡Ί

Nizhny Novgorod, Russian Federation

Polyclinic #4 Π“ΠšΠ‘ 6

πŸ‡·πŸ‡Ί

Orenburg, Russian Federation

Polyclinic #40

πŸ‡·πŸ‡Ί

Nizhny Novgorod, Russian Federation

City Polyclinic #7

πŸ‡·πŸ‡Ί

Voronezh, Russian Federation

Clinical cardiologic dispensary

πŸ‡·πŸ‡Ί

Perm, Russian Federation

City Polyclinic #1

πŸ‡·πŸ‡Ί

Rostov-on-Don, Russian Federation

Polyclinic of City Hospital #20

πŸ‡·πŸ‡Ί

Rostov-on-Don, Russian Federation

City Polyclinic #109

πŸ‡·πŸ‡Ί

Saint Petersburg, Russian Federation

City Polyclinic #116

πŸ‡·πŸ‡Ί

Saint Petersburg, Russian Federation

City policlinic #3

πŸ‡·πŸ‡Ί

Samara, Russian Federation

City polyclinic #54 / ID 065

πŸ‡·πŸ‡Ί

Saint Petersburg, Russian Federation

City Polyclinic #71

πŸ‡·πŸ‡Ί

Saint Petersburg, Russian Federation

Polyclinic #34

πŸ‡·πŸ‡Ί

Saint Petersburg, Russian Federation

City polyclinic 18 /ID 038

πŸ‡·πŸ‡Ί

Volgograd, Russian Federation

City Polyclinic #2

πŸ‡·πŸ‡Ί

Saratov, Russian Federation

City hospital

πŸ‡·πŸ‡Ί

Ufa, Russian Federation

Polyclinic # 2

πŸ‡·πŸ‡Ί

Volgograd, Russian Federation

Polyclinic #30

πŸ‡·πŸ‡Ί

Volgograd, Russian Federation

City hospital #4

πŸ‡·πŸ‡Ί

Voronezh, Russian Federation

Medical unit

πŸ‡·πŸ‡Ί

Saint Petersburg, Russian Federation

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