Clinical trial NCT04650152: Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Official title: A Prospective Observational Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertriglyceridemia
Metabolic Syndrome
Keywords: Tricor
fenofibrate
metabolic syndrome
hypertriglyceridemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.
timeFrame: 6 months
Secondary outcomes:
measure: Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
timeFrame: 6months
measure: Change of lipid profile parameters (TC, HDL, non-HDL) at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
timeFrame: 6 months
measure: Change of LDL level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.
timeFrame: 3 months
measure: Change of lipid profile parameters (TC, TG, HDL, non-HDL) at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.
timeFrame: 3 months
measure: Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1
timeFrame: 6 months
measure: Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1
timeFrame: 3 months
measure: 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.
timeFrame: 6 months
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: City Polyclinic #14 (branch office)
city: Bryansk
country: Russian Federation
facility: Clinical Diagnostic Centre
city: Cheboksary
country: Russian Federation
facility: Polyclinic #1
city: Cheboksary
country: Russian Federation
facility: Diagnostic Centre
city: Chelyabinsk
country: Russian Federation
facility: Polyclinic #1
city: Chelyabinsk
country: Russian Federation
facility: Polyclinic
city: Ekaterinburg
country: Russian Federation
facility: Polyclinic
city: Ekaterinburg
country: Russian Federation
facility: Medical center
city: Irkutsk
country: Russian Federation
facility: Polyclinic #1
city: Irkutsk
country: Russian Federation
facility: Clinical hospital
city: Irkutsk
country: Russian Federation
facility: City Polyclinic #4
city: Kaliningrad
country: Russian Federation
facility: Medical center
city: Kazan
country: Russian Federation
facility: Polyclinic
city: Kemerovo
country: Russian Federation
facility: Polyclinic #2 of Hospital #4
city: Kemerovo
country: Russian Federation
facility: Polyclinic
city: Krasnoyarsk
country: Russian Federation
facility: City polyclinic 7/ ID 015
city: Krasnoyarsk
country: Russian Federation
facility: Dispensary
city: Moscow region
country: Russian Federation
facility: Regional hospital
city: Moscow region
country: Russian Federation
facility: City Polyclinic
city: Moscow region
country: Russian Federation
facility: Medical center
city: Moscow
country: Russian Federation
facility: City Polyclinic #23
city: Moscow
country: Russian Federation
facility: City Polyclinic # 166 (branch office #2)
city: Moscow
country: Russian Federation
facility: City Polyclinic #166 (branch office #3)
city: Moscow
country: Russian Federation
facility: Clinical Diagnostic Centre #1 (branch office #4)
city: Moscow
country: Russian Federation
facility: City Polyclinic #170 (branch office #2)
city: Moscow
country: Russian Federation
facility: Medical center
city: Moscow
country: Russian Federation
facility: Polyclinic
city: Nizhniy Tagil
country: Russian Federation
facility: Polyclinic
city: Nizhny Novgorod region
country: Russian Federation
facility: Medical center
city: Nizhny Novgorod
country: Russian Federation
facility: Medical center
city: Nizhny Novgorod
country: Russian Federation
facility: Polyclinic #40
city: Nizhny Novgorod
country: Russian Federation
facility: Polyclinic of City Hospital #40
city: Orenburg
country: Russian Federation
facility: Polyclinic #4 ГКБ 6
city: Perm
country: Russian Federation
facility: Medical center
city: Perm
country: Russian Federation
facility: Clinical cardiologic dispensary
city: Perm
country: Russian Federation
facility: Medical center
city: Perm
country: Russian Federation
facility: Medical center
city: Rostov-on-Don
country: Russian Federation
facility: City Polyclinic #1 (branch office)
city: Rostov-on-Don
country: Russian Federation
facility: City Polyclinic #7
city: Rostov-on-Don
country: Russian Federation
facility: City Polyclinic #1
city: Rostov-on-Don
country: Russian Federation
facility: Polyclinic of City Hospital #20
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #109
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #109
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #116
city: Saint Petersburg
country: Russian Federation
facility: Medical unit
city: Saint Petersburg
country: Russian Federation
facility: City polyclinic #54 / ID 065
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #71
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #96
city: Saint Petersburg
country: Russian Federation
facility: Polyclinic #34
city: Samara
country: Russian Federation
facility: City policlinic #3
city: Samara
country: Russian Federation
facility: Clinical hospital
city: Samara
country: Russian Federation
facility: Medical center
city: Saratov
country: Russian Federation
facility: City Polyclinic #2
city: Smolensk
country: Russian Federation
facility: Medical center
city: Ufa
country: Russian Federation
facility: City hospital
city: Ufa
country: Russian Federation
facility: Polyclinic of City hospital #21
city: Volgograd
country: Russian Federation
facility: Polyclinic # 2
city: Volgograd
country: Russian Federation
facility: City polyclinic 18 /ID 038
city: Volgograd
country: Russian Federation
facility: Polyclinic #30
city: Volgograd
country: Russian Federation
facility: Polyclinic #28
city: Voronezh
country: Russian Federation
facility: City Polyclinic #7
city: Voronezh
country: Russian Federation
facility: City hospital #4
city: Yaroslavl
country: Russian Federation
facility: Polyclinic
Study officials:
affiliation: Abbott
name: Irina Solnyshkina
role: STUDY_DIRECTOR
References: