Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics
NCT ID: NCT06217523
Last Updated: 2024-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
700 participants
INTERVENTIONAL
2024-04-30
2025-12-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Doctor-only care; receiving standard care without genetic information
No interventions assigned to this group
Intervention Group
Pharmacist-guided care; dosing of statin medication based on genetic information
Pharmacogenomics-directed Hyperlipidaemia Management
Pharmacogenomics-directed Hyperlipidaemia Management
Interventions
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Pharmacogenomics-directed Hyperlipidaemia Management
Pharmacogenomics-directed Hyperlipidaemia Management
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
75 Years
ALL
No
Sponsors
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Collabring Pte Ltd
INDUSTRY
National University of Singapore
OTHER
Responsible Party
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Tan Su-Yin Doreen
Associate Professor
Principal Investigators
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Ying Xian Chua
Role: PRINCIPAL_INVESTIGATOR
National University Polyclinics
Central Contacts
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Other Identifiers
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2023/00280
Identifier Type: -
Identifier Source: org_study_id
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