NCT07311941

Brief Summary

Hyperlipidaemia especially elevation of low-density lipoprotein cholesterol (LDL-C) is known to be the main contributor to the development of atherosclerotic cardiovascular disease (ASCVD). Lowering LDL-C have been shown to reduce the risk of ASCVD2,3. Both the American Heart Association (AHA) and the European Society of Cardiology (ESC) advocated aggressive LDL-C target with statin being the first-line lipid-lowering therapy (LLT). However, a significant portion of patients did not attain their LDL-C goal in our locality. Statin no adherence, low uptake of adjuvant non-statin LLT, and therapeutic inertia are few potential causes for not achieving the LDL-C target. ESC recommends repeating blood test in 6-8 weeks after addition or alternation of LLT, but this recommendation was not routinely followed in current local practice due to resources constrain. This registry therefore aims to investigate the strategy of frequent monitoring of LDL-C and titration of LLT in achieving LDL-C treatment target at a dedicated specialist clinic.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
59mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Dec 2024Jun 2031

Study Start

First participant enrolled

December 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Low-density lipoprotein cholesterol (LDL-C) level

    Absolute change in low-density lipoprotein cholesterol (LDL-C) level at baseline

    Baseline

  • Low-density lipoprotein cholesterol (LDL-C) level

    Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 8

    week 8

  • Low-density lipoprotein cholesterol (LDL-C) level

    Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 26

    Week 26

  • Low-density lipoprotein cholesterol (LDL-C) level

    Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 52

    Week 52

  • Low-density lipoprotein cholesterol (LDL-C) level

    Percentage change in low-density lipoprotein cholesterol (LDL-C) level at Baseline

    Baseline

  • Low-density lipoprotein cholesterol (LDL-C) level

    Percentage change in low-density lipoprotein cholesterol (LDL-C) level at week 8

    Week 8

  • Low-density lipoprotein cholesterol (LDL-C) level

    Percentage change in low-density lipoprotein cholesterol (LDL-C) level at week 26

    Week 26

  • Low-density lipoprotein cholesterol (LDL-C) level

    Percentage change in low-density lipoprotein cholesterol (LDL-C) level at week 52

    Week 52

Secondary Outcomes (16)

  • Rate of subject meeting LDL-C target

    Week 26

  • Rate of subject meeting LDL-C target

    Week 26

  • Rate of subject meeting LDL-C target

    Week 26

  • 12-Item Short Form Survey (SF-12)

    Baseline

  • 12-Item Short Form Survey (SF-12)

    Week 8

  • +11 more secondary outcomes

Study Arms (2)

Acute Coronary Syndrome

Patient with acute coronary syndrome due to atherosclerotic coronary artery disease

Chronic coronary syndrome

Patient with chronic coronary syndrome due to atherosclerotic coronary artery disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged greater than 18 and who are admitted for a diagnosis of acute coronary syndrome (ACS) due to atherosclerotic coronary artery disease based on invasive coronary angiography will be recruited into this registry.

You may qualify if:

  • Age \>18
  • (Cohort 1) Diagnosis of acute coronary syndrome due to atherosclerotic coronary artery disease
  • (Cohort 2) Diagnosis of chronic coronary syndrome due to atherosclerotic coronary artery disease

You may not qualify if:

  • Inability to provide valid consent by the patient or his legal guardian
  • Diagnosis of ACS due to other causes than atherosclerotic coronary artery disease.
  • Psychiatric or severe neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, New Terrritories, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 31, 2025

Study Start

December 30, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations