Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics

NCT06217523 | Not Yet Recruiting DMC

• 1 other identifier: 2023/00280
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

• Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides

  Changes in LDL-C, HDL-C, Total cholesterol, and Triglycerides over 12 months

  12 months

• Change in creatine kinase

  Changes in creatine kinase from baseline to six months only if myopathy complaints were present.

  6 months

• Incidence of myopathy complaints

  Incidence of myopathy complaints at 1-month, 3-month, and 6-month

  6 months

Secondary Outcomes (6)

• (Clinician or Prescriber) Adherence to recommendations

  6 months

• Cost effectiveness analysis

  12 months

• Direct medical costs

  12 months

• Healthcare utilisation

  12 months

• Changes in health-related quality of life

  12 months

Study Arms (2)

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

Other: Pharmacogenomics-directed Hyperlipidaemia Management

Interventions

Pharmacogenomics-directed Hyperlipidaemia Management OTHER

Pharmacogenomics-directed Hyperlipidaemia Management

Intervention Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• Collabring Pte Ltd: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ying Xian Chua

  National University Polyclinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doreen Su-Yin Tan, PharmD

CONTACT

+65 8809 8018; doreen.tan.sy@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: January 22, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03