Tokyo, Nov. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059728) titled 'A Before-and-After Study on the Impact of Switching from Conventional Icosapent Ethyl (EPA) Formulations to a Self-Emulsifying High-Purity EPA Formulation on Atherosclerotic Risk' on Nov. 12.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - National Kohnodai Medical Center, Japan Institute for Health Security

Condition: Condition - dyslipidemia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study evaluates the effects of switching from a conventional EPA formulation to a self-emulsifying high-purity EPA formulation on atherosclerosis markers and peripheral nerve function in patients with dyslipidemia, using a six-month before-and-after comparison. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In this study, patients will switch from a conventional EPA formulation to a self-emulsifying high-purity EPA formulation (2 g once daily) and continue the treatment for six months. Evaluations will be conducted at two time points: before the switch and six months after the switch.

The primary endpoint will be the change in brachial-ankle pulse wave velocity (baPWV), an indicator of atherosclerosis and peripheral circulation.

Secondary endpoints will include changes in serum lipid parameters (LDL-C, HDL-C, triglycerides, and non-HDL-C), subjective assessments of symptoms such as cold sensation, numbness, and pain, as well as evaluation of diabetic peripheral neuropathy using the DPN Check device and assessment of heart rate variability (CVR-R) on electrocardiography, to investigate the effects on autonomic and peripheral nerve function.

Eligibility: Age-lower limit - 18 years-old = 3 times the upper limit of normal) or renal impairment (eGFR < 30 mL/min/1.73 m2). Patients with unstable oral drug absorption due to gastrointestinal surgery or gastrointestinal malabsorption disorders. Patients who are expected to have difficulty maintaining regular outpatient visits or adhering to the evaluation schedule due to transfer to another hospital or hospitalization during the study period. Patients who are pregnant, breastfeeding, or considered by the investigator to have the potential for pregnancy during the study period. Patients deemed by the principal investigator to be unsuitable for participation in the study. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 28 Day Date of IRB - 2025 Year 10 Month 14 Day Anticipated trial start date - 2025 Year 11 Month 20 Day Last follow-up date - 2027 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068309

Disclaimer: Curated by HT Syndication.