Guideline Oriented Approach to Lipid Lowering in Asia-Pacific

Last updated: February 22, 2025
Sponsor: Stephen Nicholls
Overall Status: Active - Recruiting

Phase

N/A

Condition

Angina

Cardiac Ischemia

Coronary Artery Disease

Treatment

Early Intervention

Clinical Study ID

NCT05325034
APCMC-1
  • Ages > 18
  • All Genders

Study Summary

Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study.

Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age

  • Admission for Type I myocardial infarction

Exclusion

Exclusion Criteria:

  • LDL <1.4mmol/L at baseline

  • Unable to provide contact details of primary care physician/general practitioner

  • Unable to provide written informed consent.

  • Unlikely to survive >12 months

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Early Intervention
Phase:
Study Start date:
September 15, 2022
Estimated Completion Date:
December 31, 2026

Study Description

The study will be conducted over two phases.

In phase I (0-6 months), participants randomized to 'early' will receive the intervention at baseline through 6 months, while those randomized to 'late' will receive standard-of-care and represent a control arm over this period.

In phase II (6 to 12 months), those randomized to 'late' will receive the intervention at 6 months, while the 'early' group will continue in follow-up.

Multifaceted Intervention The intervention aims to increase the likelihood of effecting guideline-directed change in lipid lowering therapy through two key actors - both the patient and their clinician(s). The intervention is deliberately nested within routine clinical care to enhance the generalisability of the findings beyond a research environment and to reflect other elements of real world practice.

  • Patient-and-clinician 'Cholesterol score card'. This passport-sized document will serve as a communication, engagement and activation tool for patients. It will be provided to participants at the commencement of the intervention and filled out at each study follow up visit. Participants will be encouraged to fill out sections at clinically-driven follow up appointments with their treating clinicians (e.g. general practitioner, cardiologist). The Score Card documents four key fields to be completed by the participant, study team and participant's regular clinician including 1) 'current' LDL-C level, 2) participant's level of adherence to lipid-lowering therapy using modified Voil's criteria, 3) lipid-lowering management decisions made at the clinician's appointment and 4) currently prescribed lipid-lowering therapies.

  • Risk stratification for recurrent events. As part of the intervention, each participant will have their SMART Risk score of a recurrent event assessed using the 'U-prevent' online calculator. In addition, each participant's Lp(a) will be measured and presented graphically on a continuum of risk. Both of these risk assessments will be sent to the treating primary care clinician and a copy provided to the participant.

Standard of care Participants allocated to 'late' will receive standard-of-care for the first 6 months which involves the provision of the participant's lipid profile to their nominated primary care physician/general practitioner at 6 weeks, 3 months and 6 months.

Connect with a study center

  • Illawarra Shoalhaven Local Health District

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Cairns & Hinterland Hospital & Health Service

    Cairns, Queensland 4870
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3800
    Australia

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Kyorin University Hospital

    Mitaka,
    Japan

    Site Not Available

  • National Cerebral and Cardiovascular Center

    Osaka,
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka,
    Japan

    Site Not Available

  • PyeongChon Hallym University Sacred Heart Hospital

    Pyeongchon, Gyeonggi Province
    Korea, Republic of

    Site Not Available

  • Kangnam Hallym University Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • University Teknologi MARA, Hospital UiTM, UiTM Medical Centre

    Shah Alam, Selangor
    Malaysia

    Site Not Available

  • National Heart Centre

    Singapore,
    Singapore

    Active - Recruiting

  • National University Hospital Singapore (NUHS)

    Singapore,
    Singapore

    Site Not Available

  • Ramathibodi Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Siriraj Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast

    Khon Kaen,
    Thailand

    Site Not Available

  • Central Chest Institute, Nonthaburi, Thailand

    Nonthaburi,
    Thailand

    Site Not Available

  • Songklanagarind Hospital

    Songkhla,
    Thailand

    Site Not Available

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