Guideline Oriented Approach To Lipid Lowering In Asia-Pacific
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Intervention.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Acute Coronary Syndrome, Atherosclerosis, Hypercholesterolemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, China, India, Japan, Malaysia +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)
Overview
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.
Interventions
- 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
Primary outcome measures
- Proportion of patients achieving an LDL <1.4mmol/L [Time frame: 6 months]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 5 centers
- Illawarra Shoalhaven Local Health District — Wollongong
- Cairns & Hinterland Hospital & Health Service — Cairns
- Flinders Medical Centre — Bedford Park
- Monash Health — Clayton
- Western Health — Melbourne
Japan · 4 centers
- Fukuoka University Hospital — Fukuoka
- Kyorin University Hospital — Mitaka
- National Cerebral and Cardiovascular Center — Osaka
- Osaka Medical and Pharmaceutical University Hospital — Osaka
Malaysia · 3 centers
- University Teknologi MARA, Hospital UiTM, UiTM Medical Centre — Shah Alam
- National Heart Institute — Kuala Lumpur
- University of Malaysia Medical Centre — Kuala Lumpur
Thailand · 3 centers
- Siriraj Hospital — Bangkok
- Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast — Khon Kaen
- Songklanagarind Hospital — Songkhla
Singapore · 2 centers
- National Heart Centre — Singapore
- National University Hospital Singapore (NUHS) — Singapore
South Korea · 2 centers
- PyeongChon Hallym University Sacred Heart Hospital — Pyeongchon
- Kangnam Hallym University Sacred Heart Hospital — Seoul
China · 1 center
- Affiliated Zhongshan Hospital of Dalian University — Dalian
India · 1 center
- All India Institute of Medical Sciences — New Delhi
Taiwan · 1 center
- National Cheng Kung University Hospital — Tainan
Identifiers
NCT: NCT05325034 · APCMC-1