Guideline Oriented Approach To Lipid Lowering In Asia-Pacific
GOAL-ASIA
1 other identifier
interventional
2,000
9 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Sep 2022
Longer than P75 for not_applicable cardiovascular-diseases
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedStudy Start
First participant enrolled
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
August 14, 2025
August 1, 2025
4.2 years
April 5, 2022
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Proportion of patients who undergo intensification of lipid-lowering therapy
6 months
Proportion of patients prescribed high-intensity statin
6 months
Proportion of patients prescribed high-intensity statin at 6 months
6 months
Adherence to lipid lowering therapy
6 months
Patient activation and engagement in care
6 months
- +1 more secondary outcomes
Study Arms (2)
Early intervention
ACTIVE COMPARATORParticipants 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.
Late intervention
OTHERThose randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age
- Admission for Type I myocardial infarction
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stephen Nichollslead
- Amgencollaborator
Study Sites (22)
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, 2500, Australia
Cairns & Hinterland Hospital & Health Service
Cairns, Queensland, 4870, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Health
Clayton, Victoria, 3800, Australia
Western Health
Melbourne, Victoria, 3011, Australia
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
All India Institute of Medical Sciences
New Delhi, 360110, India
Fukuoka University Hospital
Fukuoka, Japan
Kyorin University Hospital
Mitaka, Japan
National Cerebral and Cardiovascular Center
Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, Japan
University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
Shah Alam, Selangor, Malaysia
National Heart Institute
Kuala Lumpur, 50400, Malaysia
University of Malaysia Medical Centre
Kuala Lumpur, 59100, Malaysia
National Heart Centre
Singapore, Singapore
National University Hospital Singapore (NUHS)
Singapore, Singapore
PyeongChon Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggi Province, South Korea
Kangnam Hallym University Sacred Heart Hospital
Seoul, South Korea
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Siriraj Hospital
Bangkok, Thailand
Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
Khon Kaen, Thailand
Songklanagarind Hospital
Songkhla, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Nicholls, MBBS, PhD
Monash University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 13, 2022
Study Start
September 15, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share