Cardiovascular DiseasesLipidPgxNCT06217523
Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics
A study testing Pharmacogenomics-directed Hyperlipidaemia Management in people with Cardiovascular Diseases, run by National University of Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Pharmacogenomics-directed Hyperlipidaemia Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Designing Therapy to Suit You - Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (DTSY Lipid PGx): A Randomised Controlled Trial
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.
Read the 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
- Being tested
- Pharmacogenomics-directed Hyperlipidaemia Management
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomics-directed Hyperlipidaemia ManagementOther
Pharmacogenomics-directed Hyperlipidaemia Management
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Doctor-only care; receiving standard care without genetic information |
| Intervention Group | Experimental | Pharmacist-guided care; dosing of statin medication based on genetic information Receives: Other: Pharmacogenomics-directed Hyperlipidaemia Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides over 12 months
Measured: 12 months
Change in creatine kinase
Changes in creatine kinase from baseline to six months only if myopathy complaints were present.
Measured: 6 months
Incidence of myopathy complaints
Incidence of myopathy complaints at 1-month, 3-month, and 6-month
Measured: 6 months
Secondary outcomes (6)
(Clinician or Prescriber) Adherence to recommendations
The proportion of patients whose statin dose was prescribed in adherence to SLCO1B1 and/or ABCG2 phenotype recommendations, the proportion of patients with lipid-lowering drug changes following phenotype results, retrospective exploratory analyses of emerging gene predictors of lipid-control and myopathy
Measured: 6 months
Cost effectiveness analysis
Cost effectiveness analysis will be measured as total direct medical cost per disability-adjusted life year
Measured: 12 months
Direct medical costs
Total direct medical costs measured in USD will be computed from consultation costs, laboratory costs, and visits to other healthcare professionals.
Measured: 12 months
Healthcare utilisation
Healthcare utilisation will be measured as the number of visits over 12 months
Measured: 12 months
Changes in health-related quality of life
Changes in health-related quality of life will be measured using the utility score derived from EQ-5D-5L over 12 months. An improvement in scores imply a better quality of life.
Measured: 12 months
Changes to beliefs about medications
Drug-Associated Risk Tool (DART)-Beliefs about Medicines Questionnaire (BMQ) scores will be computed. It is expected for responses to become more favourable over time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Collabring Pte Ltd
- Responsible party
- Principal investigator, Tan Su-Yin Doreen, National University of Singapore
- Investigators
- Ying Xian Chua, Principal investigator, National University Polyclinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217523
- Sponsor's protocol ID
- 2023/00280
- Other IDs
- 2023
- Acronym
- LipidPgx
- Status last verified
- Mar 2024
- First submitted
- 6 Nov 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Therapy to Suit You - Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics (DTSY Lipid PGx): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06217523
- Acronym / sponsor ID
- LipidPgx / 2023/00280
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Collabring Pte Ltd
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Doctor-only care; receiving standard care without genetic information |
| Intervention Group | Experimental | Other: Pharmacogenomics-directed Hyperlipidaemia ManagementPharmacist-guided care; dosing of statin medication based on genetic information |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomics-directed Hyperlipidaemia ManagementPharmacogenomics-directed Hyperlipidaemia Management | Other | Intervention Group |
Primary outcome
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides
Time frame: 12 months
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides over 12 months
Change in creatine kinase
Time frame: 6 months
Changes in creatine kinase from baseline to six months only if myopathy complaints were present.
Incidence of myopathy complaints
Time frame: 6 months
Incidence of myopathy complaints at 1-month, 3-month, and 6-month
6 secondary outcomes
(Clinician or Prescriber) Adherence to recommendations
Time frame: 6 months
Cost effectiveness analysis
Time frame: 12 months
Direct medical costs
Time frame: 12 months
Healthcare utilisation
Time frame: 12 months
Changes in health-related quality of life
Time frame: 12 months
Changes to beliefs about medications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Related trials for Cardiovascular Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Xian Chua principal investigator
National University Polyclinics
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomics-directed Hyperlipidaemia Management in people with Cardiovascular Diseases, run by National University of Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doreen Su-Yin Tan, PharmD (+65 8809 8018, doreen.tan.sy@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.