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

Metabolic Syndrome Clinical Trial

— TRISTAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650152
• Other study ID #: FENO5002
• Status: Completed
• Start date: October 27, 2020
• Est. completion date: November 12, 2021

Study information

• Verified date: December 2021
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	City Polyclinic #14 (branch office)	Barnaul
Russian Federation	Clinical Diagnostic Centre	Bryansk
Russian Federation	Diagnostic Centre	Cheboksary
Russian Federation	Polyclinic #1	Cheboksary
Russian Federation	Polyclinic	Chelyabinsk
Russian Federation	Polyclinic #1	Chelyabinsk
Russian Federation	Medical center	Ekaterinburg
Russian Federation	Polyclinic	Ekaterinburg
Russian Federation	City Polyclinic #4	Irkutsk
Russian Federation	Clinical hospital	Irkutsk
Russian Federation	Polyclinic #1	Irkutsk
Russian Federation	Medical center	Kaliningrad
Russian Federation	Polyclinic	Kazan
Russian Federation	Polyclinic	Kemerovo
Russian Federation	Polyclinic #2 of Hospital #4	Kemerovo
Russian Federation	City polyclinic 7/ ID 015	Krasnoyarsk
Russian Federation	Dispensary	Krasnoyarsk
Russian Federation	City Polyclinic # 166 (branch office #2)	Moscow
Russian Federation	City Polyclinic #166 (branch office #3)	Moscow
Russian Federation	City Polyclinic #170 (branch office #2)	Moscow
Russian Federation	City Polyclinic #23	Moscow
Russian Federation	Clinical Diagnostic Centre #1 (branch office #4)	Moscow
Russian Federation	Medical center	Moscow
Russian Federation	Polyclinic	Moscow
Russian Federation	City Polyclinic	Moscow region
Russian Federation	Medical center	Moscow region
Russian Federation	Regional hospital	Moscow region
Russian Federation	Polyclinic	Nizhniy Tagil
Russian Federation	Medical center	Nizhny Novgorod
Russian Federation	Polyclinic #40	Nizhny Novgorod
Russian Federation	Polyclinic of City Hospital #40	Nizhny Novgorod
Russian Federation	Medical center	Nizhny Novgorod region
Russian Federation	Polyclinic #4 ??? 6	Orenburg
Russian Federation	Clinical cardiologic dispensary	Perm
Russian Federation	Medical center	Perm
Russian Federation	Medical center	Perm
Russian Federation	Medical center	Perm
Russian Federation	City Polyclinic #1	Rostov-on-Don
Russian Federation	City Polyclinic #1 (branch office)	Rostov-on-Don
Russian Federation	City Polyclinic #7	Rostov-on-Don
Russian Federation	Polyclinic of City Hospital #20	Rostov-on-Don
Russian Federation	City Polyclinic #109	Saint Petersburg
Russian Federation	City Polyclinic #109	Saint Petersburg
Russian Federation	City Polyclinic #116	Saint Petersburg
Russian Federation	City polyclinic #54 / ID 065	Saint Petersburg
Russian Federation	City Polyclinic #71	Saint Petersburg
Russian Federation	City Polyclinic #96	Saint Petersburg
Russian Federation	Medical unit	Saint Petersburg
Russian Federation	Polyclinic #34	Saint Petersburg
Russian Federation	City policlinic #3	Samara
Russian Federation	Clinical hospital	Samara
Russian Federation	Medical center	Samara
Russian Federation	City Polyclinic #2	Saratov
Russian Federation	Medical center	Smolensk
Russian Federation	City hospital	Ufa
Russian Federation	Polyclinic of City hospital #21	Ufa
Russian Federation	City polyclinic 18 /ID 038	Volgograd
Russian Federation	Polyclinic # 2	Volgograd
Russian Federation	Polyclinic #28	Volgograd
Russian Federation	Polyclinic #30	Volgograd
Russian Federation	City hospital #4	Voronezh
Russian Federation	City Polyclinic #7	Voronezh
Russian Federation	Polyclinic	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1	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.	6months
Secondary	Change of lipid profile parameters (TC, HDL, non-HDL) at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1	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.	6 months
Secondary	Change of LDL level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.	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.	3 months
Secondary	Change of lipid profile parameters (TC, TG, HDL, non-HDL) at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.	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.	3 months
Secondary	Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1	?hange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 3 vs. Visit 1.	6 months
Secondary	Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1	?hange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 2 vs. Visit 1.	3 months
Secondary	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.	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.	6 months
Secondary	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	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.	3 months