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

NCT ID: NCT04650152

Last Updated: 2021-12-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2021-11-12

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.

Conditions

Hypertriglyceridemia; Metabolic Syndrome

Keywords

Tricor; fenofibrate; metabolic syndrome; hypertriglyceridemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Tricor (fenofibrate), 145 mg, film-coated tablet

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Tricor

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irina Solnyshkina

Role: STUDY_DIRECTOR

Abbott

Locations

City Polyclinic #14 (branch office)

Barnaul, , Russia

Clinical Diagnostic Centre

Bryansk, , Russia

Polyclinic #1

Cheboksary, , Russia

Diagnostic Centre

Cheboksary, , Russia

Polyclinic #1

Chelyabinsk, , Russia

Polyclinic

Chelyabinsk, , Russia

Polyclinic #1

Irkutsk, , Russia

Clinical hospital

Irkutsk, , Russia

City Polyclinic #4

Irkutsk, , Russia

Medical center

Kaliningrad, , Russia

Polyclinic

Kazan', , Russia

Polyclinic #2 of Hospital #4

Kemerovo, , Russia

Polyclinic

Kemerovo, , Russia

City polyclinic 7/ ID 015

Krasnoyarsk, , Russia

Dispensary

Krasnoyarsk, , Russia

City Polyclinic #23

Moscow, , Russia

City Polyclinic # 166 (branch office #2)

Moscow, , Russia

City Polyclinic #166 (branch office #3)

Moscow, , Russia

Clinical Diagnostic Centre #1 (branch office #4)

Moscow, , Russia

City Polyclinic #170 (branch office #2)

Moscow, , Russia

Medical center

Moscow, , Russia

Polyclinic

Moscow, , Russia

Regional hospital

Moscow Region, , Russia

City Polyclinic

Moscow Region, , Russia

Medical center

Moscow Region, , Russia

Medical center

Nizhny Novgorod, , Russia

Polyclinic #40

Nizhny Novgorod, , Russia

Polyclinic of City Hospital #40

Nizhny Novgorod, , Russia

Medical center

Nizhny Novgorod Region, , Russia

Polyclinic

Nizhny Tagil, , Russia

Polyclinic #4 ГКБ 6

Orenburg, , Russia

Medical center

Perm, , Russia

Clinical cardiologic dispensary

Perm, , Russia

Medical center

Perm, , Russia

Medical center

Perm, , Russia

City Polyclinic #1 (branch office)

Rostov-on-Don, , Russia

City Polyclinic #7

Rostov-on-Don, , Russia

City Polyclinic #1

Rostov-on-Don, , Russia

Polyclinic of City Hospital #20

Rostov-on-Don, , Russia

City Polyclinic #109

Saint Petersburg, , Russia

City Polyclinic #109

Saint Petersburg, , Russia

City Polyclinic #116

Saint Petersburg, , Russia

Medical unit

Saint Petersburg, , Russia

City polyclinic #54 / ID 065

Saint Petersburg, , Russia

City Polyclinic #71

Saint Petersburg, , Russia

City Polyclinic #96

Saint Petersburg, , Russia

Polyclinic #34

Saint Petersburg, , Russia

City policlinic #3

Samara, , Russia

Clinical hospital

Samara, , Russia

Medical center

Samara, , Russia

City Polyclinic #2

Saratov, , Russia

Medical center

Smolensk, , Russia

City hospital

Ufa, , Russia

Polyclinic of City hospital #21

Ufa, , Russia

Polyclinic # 2

Volgograd, , Russia

City polyclinic 18 /ID 038

Volgograd, , Russia

Polyclinic #30

Volgograd, , Russia

Polyclinic #28

Volgograd, , Russia

City Polyclinic #7

Voronezh, , Russia

City hospital #4

Voronezh, , Russia

Polyclinic

Yaroslavl, , Russia

Polyclinic

Yekaterinburg, , Russia

Medical center

Yekaterinburg, , Russia

Countries

Russia

Other Identifiers

FENO5002

Identifier Type: -

Identifier Source: org_study_id