NCT06217523

Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics

Designing Therapy to Suit You - Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (DTSY Lipid PGx): A Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to evaluate the impact of clinical pharmacists' pharmacogenomics-guided choice and statin titration for managing hyperlipidaemia. The central hypotheses of this trial are (1) clinical pharmacists' pharmacogenomics-guided choice and titration of statins will lead to a more significant reduction in LDL-c; (2) lower incidence of myopathies with the use of statins for hyperlipidaemia management over 12 months compared to usual care by doctors alone. Active follow-up and titration should occur over the first six months. However, the participants will be followed up to 12 months to confirm the sustained LDL level attainment.

Detailed description

The primary aims are: * The changes in Low-Density Lipoprotein cholesterol (LDL-c), total cholesterol, triglycerides (TG), and high-density lipoprotein cholesterol (HDL-c) levels, and * The incidence of myopathies over 12 months. The secondary aims include: * Characterisation of the pharmacogenomic relationship between serum levels of statins (and their metabolites) with the changes in LDL-c levels and incidence of myopathies over six months * Economic outcomes include but are not limited to the cost-effectiveness of pharmacogenomic testing in attaining LDL-c targets * Change in health-related quality of life over 12 months is measured using the EuroQoL 5-Dimension 5-Level questionnaire

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Pharmacogenomics-directed Hyperlipidaemia Management	Pharmacogenomics-directed Hyperlipidaemia Management

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-01-22
• Last updated: 2024-03-27