Status:

NOT_YET_RECRUITING

Personalised Hyperlipidaemia Therapies Guided by Pharmacogenomics

Lead Sponsor:

National University of Singapore

Collaborating Sponsors:

Collabring Pte Ltd

Conditions:

Cardiovascular Diseases

Eligibility:

All Genders

21-75 years

Phase:

NA

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...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

700 Patients enrolled

Trial Details

Trial ID

NCT06217523

Start Date

April 1 2024

End Date

December 1 2025

Last Update

March 27 2024

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