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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT04650152

Collaborator

(none)

1,000

Enrollment

Locations

12.5

Actual Duration (Months)

15.9

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia Metabolic Syndrome	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 Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 27, 2020

Actual Primary Completion Date :

Nov 12, 2021

Actual Study Completion Date :

Nov 12, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1 [6months]
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 1 [6 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 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 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1 [6 months]
Сhange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 3 vs. Visit 1.
Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1 [3 months]
Сhange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 2 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 1 [3 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	City Polyclinic #14 (branch office)	Barnaul	Russian Federation	656067
2	Clinical Diagnostic Centre	Bryansk	Russian Federation	241050
3	Polyclinic #1	Cheboksary	Russian Federation	428027
4	Diagnostic Centre	Cheboksary	Russian Federation	428034
5	Polyclinic #1	Chelyabinsk	Russian Federation	454071
6	Polyclinic	Chelyabinsk	Russian Federation	454091
7	Polyclinic	Ekaterinburg	Russian Federation	620014
8	Medical center	Ekaterinburg	Russian Federation	620026
9	Polyclinic #1	Irkutsk	Russian Federation	664046
10	Clinical hospital	Irkutsk	Russian Federation	664049
11	City Polyclinic #4	Irkutsk	Russian Federation	664058
12	Medical center	Kaliningrad	Russian Federation	236001
13	Polyclinic	Kazan	Russian Federation	420059
14	Polyclinic #2 of Hospital #4	Kemerovo	Russian Federation	650024
15	Polyclinic	Kemerovo	Russian Federation	650033
16	City polyclinic 7/ ID 015	Krasnoyarsk	Russian Federation	660021
17	Dispensary	Krasnoyarsk	Russian Federation	660123
18	Regional hospital	Moscow region	Russian Federation	141103
19	City Polyclinic	Moscow region	Russian Federation	142203
20	Medical center	Moscow region	Russian Federation	143985
21	City Polyclinic #23	Moscow	Russian Federation	109431
22	City Polyclinic # 166 (branch office #2)	Moscow	Russian Federation	115304
23	City Polyclinic #166 (branch office #3)	Moscow	Russian Federation	115582
24	Clinical Diagnostic Centre #1 (branch office #4)	Moscow	Russian Federation	117513
25	City Polyclinic #170 (branch office #2)	Moscow	Russian Federation	117519
26	Medical center	Moscow	Russian Federation	125414
27	Polyclinic	Moscow	Russian Federation	127562
28	Polyclinic	Nizhniy Tagil	Russian Federation	622049
29	Medical center	Nizhny Novgorod region	Russian Federation	606440
30	Medical center	Nizhny Novgorod	Russian Federation	603004
31	Polyclinic #40	Nizhny Novgorod	Russian Federation	603004
32	Polyclinic of City Hospital #40	Nizhny Novgorod	Russian Federation	603004
33	Polyclinic #4 ГКБ 6	Orenburg	Russian Federation	460000
34	Medical center	Perm	Russian Federation	614000
35	Clinical cardiologic dispensary	Perm	Russian Federation	614002
36	Medical center	Perm	Russian Federation	614012
37	Medical center	Perm	Russian Federation	614107
38	City Polyclinic #1 (branch office)	Rostov-on-Don	Russian Federation	344000
39	City Polyclinic #7	Rostov-on-Don	Russian Federation	344011
40	City Polyclinic #1	Rostov-on-Don	Russian Federation	344029
41	Polyclinic of City Hospital #20	Rostov-on-Don	Russian Federation	344091
42	City Polyclinic #109	Saint Petersburg	Russian Federation	121096
43	City Polyclinic #109	Saint Petersburg	Russian Federation	192283
44	City Polyclinic #116	Saint Petersburg	Russian Federation	194356
45	Medical unit	Saint Petersburg	Russian Federation	195009
46	City polyclinic #54 / ID 065	Saint Petersburg	Russian Federation	195197
47	City Polyclinic #71	Saint Petersburg	Russian Federation	196650
48	City Polyclinic #96	Saint Petersburg	Russian Federation	197022
49	Polyclinic #34	Saint Petersburg	Russian Federation	197198
50	City policlinic #3	Samara	Russian Federation	443010
51	Clinical hospital	Samara	Russian Federation	443067
52	Medical center	Samara	Russian Federation	443068
53	City Polyclinic #2	Saratov	Russian Federation	410005
54	Medical center	Smolensk	Russian Federation	214018
55	City hospital	Ufa	Russian Federation	450050
56	Polyclinic of City hospital #21	Ufa	Russian Federation	450071
57	Polyclinic # 2	Volgograd	Russian Federation	400007
58	City polyclinic 18 /ID 038	Volgograd	Russian Federation	400075
59	Polyclinic #30	Volgograd	Russian Federation	400081
60	Polyclinic #28	Volgograd	Russian Federation	400137
61	City Polyclinic #7	Voronezh	Russian Federation	394051
62	City hospital #4	Voronezh	Russian Federation	394077
63	Polyclinic	Yaroslavl	Russian Federation	150062