Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: Early Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Butters, BHSc, MBA; Phone Number: 61 434679018; Email: julie.butters@monash.edu

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Illawarra Shoalhaven Local Health District
      • Contact: Stephen Mackay
      • Principal Investigator: Astin Lee
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Recruiting
      • Cairns & Hinterland Hospital & Health Service
      • Contact: Sue Dixon
      • Principal Investigator: Gregory Starmer
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Not yet recruiting
      • Flinders Medical Centre
      • Contact: Fiona Wollaston
      • Principal Investigator: Philip Aylward
  • Victoria
    • Clayton, Victoria, Australia, 3800
      • Recruiting
      • Monash Health
      • Principal Investigator: Stephen Nicholls, MBBS
      • Principal Investigator: Adam Nelson, MBBS
      • Contact: Domenic Sacca; Phone Number: +61423245187; Email: domenic.sacca@monash.edu
    • Melbourne, Victoria, Australia, 3011
      • Recruiting
      • Western Health
      • Contact: Samantha Bates; Phone Number: +61-03-8345-6666; Email: Samantha.bates@wh.org.au
      • Principal Investigator: Omar Al-Mukhtar
• China
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Recruiting
      • Affiliated Zhongshan Hospital of Dalian University
      • Contact: Minglian Gong; Phone Number: +86 411 8561 4849; Email: gongml777@126.com
      • Principal Investigator: Minglian Gong
• India
  • New Delhi, India, 360110
    • Recruiting
    • All India Institute of Medical Sciences
    • Contact: Ragini Singh; Phone Number: +91 281 299 4269; Email: singh.ragini28@yahoo.com
    • Principal Investigator: Ragini Singh
• Japan
  • Fukuoka, Japan
    • Not yet recruiting
    • Fukuoka University Hospital
    • Contact: Kohei Takata
    • Principal Investigator: Kohei Takata
  • Mitaka, Japan
    • Not yet recruiting
    • Kyorin University Hospital
    • Contact: Sayaka Funabashi
    • Principal Investigator: Sayaka Funabashi
  • Osaka, Japan
    • Recruiting
    • National Cerebral and Cardiovascular Center
    • Contact: Yu Kataoka
    • Principal Investigator: Yu Kataoka
    • Sub-Investigator: Satoshi Honda
  • Osaka, Japan
    • Not yet recruiting
    • Osaka Medical and Pharmaceutical University Hospital
    • Contact: Daisuke Shishikura
    • Principal Investigator: Daisuke Shishikura
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Kangnam Hallym University Sacred Heart Hospital
    • Contact: Jung-Rae Cho
    • Principal Investigator: Jung-rae Cho, MD
  • Gyeonggi Province
    • Pyeongchon, Gyeonggi Province, Korea, Republic of
      • Not yet recruiting
      • PyeongChon Hallym University Sacred Heart Hospital
      • Contact: Sang-Ho Jo
      • Principal Investigator: Sang-Ho Jo, MD
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • Recruiting
    • National Heart Institute
    • Contact: Fatini Husain; Phone Number: +60 3-2617 8200; Email: nfatini@ijn.com.my
    • Principal Investigator: Rafidah Abu Bakar
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University of Malaysia Medical Centre
    • Contact: Hidayah Nasir; Phone Number: +60 3-106521896; Email: Hidayahmdnasir@gmail.com
    • Principal Investigator: Syadi Mahmood Zuhdi
  • Selangor
    • Shah Alam, Selangor, Malaysia
      • Not yet recruiting
      • University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
      • Contact: Sazzli Kasim
      • Principal Investigator: Sazzli Kasim
• Singapore
  • Singapore, Singapore
    • Recruiting
    • National Heart Centre
    • Contact: Khung Keong Yeo
    • Principal Investigator: Khung Keong Yeo
  • Singapore, Singapore
    • Not yet recruiting
    • National University Hospital Singapore (NUHS)
    • Principal Investigator: Mark Chan
    • Contact: Sock-Hwee Tan
• Taiwan
  • Tainan, Taiwan, 70403
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Wen-hui Tseng; Phone Number: +886 6 275 7575; Email: iamywen@gmail.com
    • Principal Investigator: Yi-Heng Li
• Thailand
  • Bangkok, Thailand
    • Not yet recruiting
    • Siriraj Hospital
    • Contact: Rungroj Krittayaphong
    • Principal Investigator: Rungroj Krittayaphong
  • Khon Kaen, Thailand
    • Not yet recruiting
    • Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
    • Contact: Burabha Pussadhamma
    • Principal Investigator: Burabha Pussadhamma
  • Songkhla, Thailand
    • Not yet recruiting
    • Songklanagarind Hospital
    • Contact: Ply Chichareon
    • Principal Investigator: Ply Chichareon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age
• Admission for Type I myocardial infarction

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early intervention; Participants randomised to 'early' will receive the intervention at baseline through 6 months. while those randomised to 'late' will receive standard-of-care and represent a control arm over this period.	Behavioral: Early Intervention; Participant and clinician lipid score card 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 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.
Other: Late intervention; Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group.	Behavioral: Early Intervention; Participant and clinician lipid score card 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving an LDL <1.4mmol/L	Proportion of patients achieving an LDL <1.4mmol/L at 6 months. This will be determined from values obtained through local laboratory testing.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who undergo intensification of lipid-lowering therapy	Proportion of patients who undergo intensification of lipid-lowering therapy in 6 months	6 months
Proportion of patients prescribed high-intensity statin	Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months	6 months
Proportion of patients prescribed high-intensity statin at 6 months	Proportion of patients prescribed a guideline-recommended high-intensity statin at 6 months	6 months
Adherence to lipid lowering therapy	Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months	6 months
Patient activation and engagement in care	Level of patient activation and engagement in their care at 6 months compared with baseline	6 months
Proportion of patients achieving LDL<1.4mmol/L at 12 months	Proportion of patients achieving LDL<1.4mmol/L at 12 months	12 months

Collaborators and Investigators

• Sponsor: Stephen Nicholls
• Collaborators: Amgen
• Investigators: Principal Investigator: Stephen Nicholls, MBBS, PhD, Monash University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cholesterol; Acute Coronary Syndrome; Lipid management
• Additional Relevant MeSH Terms: Vascular Diseases; Heart Diseases; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis; Acute Coronary Syndrome
• Other Study ID Numbers: APCMC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No