Cardiovascular DiseasesGOAL-ASIANCT05325034
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific
A study testing Early Intervention in people with Cardiovascular Diseases and Acute Coronary Syndrome, run by Stephen Nicholls at 22 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Acute Coronary Syndrome, Atherosclerosis
- What is being tested?
- Early Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 22 sitesin 9 countries
- Study dates
- 15 Sep 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Admission for Type I myocardial infarction
Who cannot join
- 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
Trial locations and contacts
22 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 9 countries
Australia5 sites, 5 recruiting
- Not yet recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Fiona Wollaston
Philip Aylward
- Recruiting
Cairns & Hinterland Hospital & Health Service
Cairns, Queensland, 4870
Sue Dixon
Gregory Starmer
- Recruiting
Monash Health
Clayton, Victoria, 3800
Domenic Sacca, +61423245187, domenic.sacca@monash.edu
Stephen Nicholls, MBBS
- Recruiting
Western Health
Melbourne, Victoria, 3011
Samantha Bates, +61-03-8345-6666, Samantha.bates@wh.org.au
Omar Al-Mukhtar
- Recruiting
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, 2500
Stephen Mackay
Astin Lee
Japan4 sites, 4 recruiting
- Not yet recruiting
Fukuoka University Hospital
Fukuoka
Kohei Takata
Kohei Takata
- Not yet recruiting
Kyorin University Hospital
Mitaka
Sayaka Funabashi
Sayaka Funabashi
- Recruiting
National Cerebral and Cardiovascular Center
Osaka
Yu Kataoka
Yu Kataoka
- Not yet recruiting
Osaka Medical and Pharmaceutical University Hospital
Osaka
Daisuke Shishikura
Daisuke Shishikura
Malaysia3 sites, 3 recruiting
- Recruiting
National Heart Institute
Kuala Lumpur, 50400
Fatini Husain, +60 3-2617 8200, nfatini@ijn.com.my
Rafidah Abu Bakar
- Recruiting
University of Malaysia Medical Centre
Kuala Lumpur, 59100
Hidayah Nasir, +60 3-106521896, Hidayahmdnasir@gmail.com
Syadi Mahmood Zuhdi
- Not yet recruiting
University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
Shah Alam, Selangor
Sazzli Kasim
Sazzli Kasim
Thailand3 sites, 3 recruiting
- Not yet recruiting
Siriraj Hospital
Bangkok
Rungroj Krittayaphong
Rungroj Krittayaphong
- Not yet recruiting
Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
Khon Kaen
Burabha Pussadhamma
Burabha Pussadhamma
- Not yet recruiting
Songklanagarind Hospital
Songkhla
Ply Chichareon
Ply Chichareon
Singapore2 sites, 2 recruiting
- Recruiting
National Heart Centre
Singapore
Khung Keong Yeo
Khung Keong Yeo
- Not yet recruiting
National University Hospital Singapore (NUHS)
Singapore
Sock-Hwee Tan
Mark Chan
South Korea2 sites, 2 recruiting
- Not yet recruiting
PyeongChon Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggi Province
Sang-Ho Jo
Sang-Ho Jo, MD
- Not yet recruiting
Kangnam Hallym University Sacred Heart Hospital
Seoul
Jung-Rae Cho
Jung-Rae Cho, MD
China1 site, 1 recruiting
- Recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Minglian Gong, +86 411 8561 4849, gongml777@126.com
Minglian Gong
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, 360110
Ragini Singh, +91 281 299 4269, singh.ragini28@yahoo.com
Ragini Singh
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
Wen-hui Tseng, +886 6 275 7575, iamywen@gmail.com
Yi-Heng Li
About this study
Official title: 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.
Read the 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.
- Being tested
- Early Intervention
- Keywords
- Acute Coronary Syndrome, Lipid management, Cholesterol
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome, Atherosclerosis, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Active comparator | 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. Receives: Behavioral: Early Intervention |
| Late intervention | Other | Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group. Receives: Behavioral: Early Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Proportion of patients who undergo intensification of lipid-lowering therapy
Proportion of patients who undergo intensification of lipid-lowering therapy in 6 months
Measured: 6 months
Proportion of patients prescribed high-intensity statin
Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months
Measured: 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
Measured: 6 months
Adherence to lipid lowering therapy
Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months
Measured: 6 months
Patient activation and engagement in care
Level of patient activation and engagement in their care at 6 months compared with baseline
Measured: 6 months
Proportion of patients achieving LDL<1.4mmol/L at 12 months
Proportion of patients achieving LDL<1.4mmol/L at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start15 Sep 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephen Nicholls
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Stephen Nicholls, Monash University
- Investigators
- Stephen Nicholls, MBBS, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325034
- Sponsor's protocol ID
- APCMC-1
- Acronym
- GOAL-ASIA
- Status last verified
- Oct 2026
- First submitted
- 5 Apr 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)
- ClinicalTrials.gov ID
- NCT05325034
- Acronym / sponsor ID
- GOAL-ASIA / APCMC-1
- Keywords
- Acute Coronary Syndrome, Lipid management, Cholesterol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Stephen NichollsUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Active comparator | Behavioral: Early InterventionParticipants 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 | Other | Behavioral: Early InterventionThose randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age
- Admission for Type I myocardial infarction
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early InterventionParticipant 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. | Behavioural | Early intervention, Late intervention |
Primary outcome
Proportion of patients achieving an LDL <1.4mmol/L
Time frame: 6 months
Proportion of patients achieving an LDL <1.4mmol/L at 6 months. This will be determined from values obtained through local laboratory testing.
6 secondary outcomes
Proportion of patients who undergo intensification of lipid-lowering therapy
Time frame: 6 months
Proportion of patients prescribed high-intensity statin
Time frame: 6 months
Proportion of patients prescribed high-intensity statin at 6 months
Time frame: 6 months
Adherence to lipid lowering therapy
Time frame: 6 months
Patient activation and engagement in care
Time frame: 6 months
Proportion of patients achieving LDL<1.4mmol/L at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Nicholls, MBBS, PhD principal investigator
Monash University
22 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intervention in people with Cardiovascular Diseases and Acute Coronary Syndrome, run by Stephen Nicholls at 22 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Australia, Japan, Malaysia, Thailand, Singapore and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Butters, BHSc, MBA (61 434679018, julie.butters@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving an LDL <1.4mmol/L (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.