Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04650152
Study type	Observational
Source	Abbott
Contact
Status	Completed
Phase
Start date	October 27, 2020
Completion date	November 12, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04635202` - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome	N/A
Completed	`NCT04053686` - An Intervention to Reduce Prolonged Sitting in Police Staff	N/A
Completed	`NCT05343858` - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome	N/A
Active, not recruiting	`NCT05891834` - Study of INV-202 in Patients With Obesity and Metabolic Syndrome	Phase 2
Recruiting	`NCT05040958` - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
Recruiting	`NCT03227575` - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control	N/A
Recruiting	`NCT05972564` - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function	Phase 1/Phase 2
Completed	`NCT03289897` - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan	N/A
Recruiting	`NCT05956886` - Sleep Chatbot Intervention for Emerging Black/African American Adults	N/A
Completed	`NCT06057896` - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting	`NCT03613740` - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion	Phase 2
Completed	`NCT04498455` - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency	Phase 4
Completed	`NCT05688917` - Green Coffee Effect on Metabolic Syndrome	N/A
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT03697382` - Effect of Daily Steps on Fat Metabolism	N/A
Completed	`NCT03241121` - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome	N/A
Completed	`NCT04509206` - Virtual Teaching Kitchen	N/A
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms