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

NCT04650152 | Completed

• 1 other identifier: FENO5002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 63

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.

Conditions

Hypertriglyceridemia; Metabolic Syndrome

Keywords

Tricor; fenofibrate; metabolic syndrome; hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  6 months

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

  3 months

• Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1

  6 months

Study Arms (1)

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

Interventions

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

Also known as: Tricor

Fenofibrate

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (63)

City Polyclinic #14 (branch office)

Barnaul, 656067, Russia

Location

Clinical Diagnostic Centre

Bryansk, 241050, Russia

Location

Polyclinic #1

Cheboksary, 428027, Russia

Location

Diagnostic Centre

Cheboksary, 428034, Russia

Location

Polyclinic #1

Chelyabinsk, 454071, Russia

Location

Polyclinic

Chelyabinsk, 454091, Russia

Location

Polyclinic #1

Irkutsk, 664046, Russia

Location

Clinical hospital

Irkutsk, 664049, Russia

Location

City Polyclinic #4

Irkutsk, 664058, Russia

Location

Medical center

Kaliningrad, 236001, Russia

Location

Polyclinic

Kazan', 420059, Russia

Location

Polyclinic #2 of Hospital #4

Kemerovo, 650024, Russia

Location

Polyclinic

Kemerovo, 650033, Russia

Location

City polyclinic 7/ ID 015

Krasnoyarsk, 660021, Russia

Location

Dispensary

Krasnoyarsk, 660123, Russia

Location

City Polyclinic #23

Moscow, 109431, Russia

Location

City Polyclinic # 166 (branch office #2)

Moscow, 115304, Russia

Location

City Polyclinic #166 (branch office #3)

Moscow, 115582, Russia

Location

Clinical Diagnostic Centre #1 (branch office #4)

Moscow, 117513, Russia

Location

City Polyclinic #170 (branch office #2)

Moscow, 117519, Russia

Location

Medical center

Moscow, 125414, Russia

Location

Polyclinic

Moscow, 127562, Russia

Location

Regional hospital

Moscow Region, 141103, Russia

Location

City Polyclinic

Moscow Region, 142203, Russia

Location

Medical center

Moscow Region, 143985, Russia

Location

Medical center

Nizhny Novgorod, 603004, Russia

Location

Polyclinic #40

Nizhny Novgorod, 603004, Russia

Location

Polyclinic of City Hospital #40

Nizhny Novgorod, 603004, Russia

Location

Medical center

Nizhny Novgorod Region, 606440, Russia

Location

Polyclinic

Nizhny Tagil, 622049, Russia

Location

Polyclinic #4 ГКБ 6

Orenburg, 460000, Russia

Location

Medical center

Perm, 614000, Russia

Location

Clinical cardiologic dispensary

Perm, 614002, Russia

Location

Medical center

Perm, 614012, Russia

Location

Medical center

Perm, 614107, Russia

Location

City Polyclinic #1 (branch office)

Rostov-on-Don, 344000, Russia

Location

City Polyclinic #7

Rostov-on-Don, 344011, Russia

Location

City Polyclinic #1

Rostov-on-Don, 344029, Russia

Location

Polyclinic of City Hospital #20

Rostov-on-Don, 344091, Russia

Location

City Polyclinic #109

Saint Petersburg, 121096, Russia

Location

City Polyclinic #109

Saint Petersburg, 192283, Russia

Location

City Polyclinic #116

Saint Petersburg, 194356, Russia

Location

Medical unit

Saint Petersburg, 195009, Russia

Location

City polyclinic #54 / ID 065

Saint Petersburg, 195197, Russia

Location

City Polyclinic #71

Saint Petersburg, 196650, Russia

Location

City Polyclinic #96

Saint Petersburg, 197022, Russia

Location

Polyclinic #34

Saint Petersburg, 197198, Russia

Location

City policlinic #3

Samara, 443010, Russia

Location

Clinical hospital

Samara, 443067, Russia

Location

Medical center

Samara, 443068, Russia

Location

City Polyclinic #2

Saratov, 410005, Russia

Location

Medical center

Smolensk, 214018, Russia

Location

City hospital

Ufa, 450050, Russia

Location

Polyclinic of City hospital #21

Ufa, 450071, Russia

Location

Polyclinic # 2

Volgograd, 400007, Russia

Location

City polyclinic 18 /ID 038

Volgograd, 400075, Russia

Location

Polyclinic #30

Volgograd, 400081, Russia

Location

Polyclinic #28

Volgograd, 400137, Russia

Location

City Polyclinic #7

Voronezh, 394051, Russia

Location

City hospital #4

Voronezh, 394077, Russia

Location

Polyclinic

Yaroslavl, 150062, Russia

Location

Polyclinic

Yekaterinburg, 620014, Russia

Location

Medical center

Yekaterinburg, 620026, Russia

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Metabolic Syndrome

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Irina Solnyshkina

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 2, 2020
• Study Start: October 27, 2020
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (63)