Clinical trial NCT06217523: Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics
Official title: Designing Therapy to Suit You - Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (DTSY Lipid PGx): A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Collabring Pte Ltd
First posted: 2024-01-22
Enrollment: 700
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Participants between 21 and 75 years old
* Participants who are planning to start on statin\* medication or whose LDL-c goals have not been met, per Appendix B.
* Participants who are able to communicate in English, Chinese or Malay.

Participants who are planning to start or will be started on the following doses are eligible: atorvastatin 10-80 mg/day, rosuvastatin 10-40 mg/day, or simvastatin 10-40 mg/day within the last two to four weeks before enrolment

Exclusion Criteria:

* Participants who are statin-intolerant or in whom statins are contraindicated
* Participants on a statin dosing schedule of every other day (EOD)
* Participants administered on potent Cytochrome P450 3A4 (CYP3A4) or Cytochrome P450 2C9 (CYP2C9) or OATP inhibitors or inducers.
* Participants on evolocumab and alirocumab prior to enrolment
* Participants with documented diagnosis of psychiatric conditions
* Participants requiring palliative care, end-of-life care, or those with a life expectancy of less than one year
* Pregnant and lactating women
* Participants with complaints of myalgia or muscle weakness at baseline, before the commencement of statin
* Participants who are unable to swallow a whole statin tablet

Primary outcomes:
measure: Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides
timeFrame: 12 months
measure: Change in creatine kinase
timeFrame: 6 months
measure: Incidence of myopathy complaints
timeFrame: 6 months
Secondary outcomes:
measure: (Clinician or Prescriber) Adherence to recommendations
timeFrame: 6 months
measure: Cost effectiveness analysis
timeFrame: 12 months
measure: Direct medical costs
timeFrame: 12 months
measure: Healthcare utilisation
timeFrame: 12 months
measure: Changes in health-related quality of life
timeFrame: 12 months
measure: Changes to beliefs about medications
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: National University Polyclinics
name: Ying Xian Chua
role: PRINCIPAL_INVESTIGATOR
References: