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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05325034




Registration number
NCT05325034
Ethics application status
Date submitted
5/04/2022
Date registered
13/04/2022
Date last updated
8/06/2023

Titles & IDs
Public title
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific
Scientific title
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)
Secondary ID [1] 0 0
APCMC-1
Universal Trial Number (UTN)
Trial acronym
GOAL-ASIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Acute Coronary Syndrome 0 0
Atherosclerosis 0 0
Hypercholesterolemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Early Intervention

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.

Other: Late intervention - Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group.


Behaviour: 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.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients achieving an LDL <1.4mmol/L
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Proportion of patients who undergo intensification of lipid-lowering therapy
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Proportion of patients prescribed high-intensity statin
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Proportion of patients prescribed high-intensity statin at 6 months
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Adherence to lipid lowering therapy
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Patient activation and engagement in care
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Proportion of patients achieving LDL<1.4mmol/L at 12 months
Timepoint [6] 0 0
12 months

Eligibility
Key inclusion criteria
- 18 years of age

- Admission for Type I myocardial infarction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [2] 0 0
Cairns & Hinterland Hospital & Health Service - Cairns
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3800 - Clayton
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Fukuoka
Country [2] 0 0
Japan
State/province [2] 0 0
Mitaka
Country [3] 0 0
Japan
State/province [3] 0 0
Osaka
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Gyeonggi Province
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
Malaysia
State/province [6] 0 0
Selangor
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore
Country [8] 0 0
Thailand
State/province [8] 0 0
Bangkok
Country [9] 0 0
Thailand
State/province [9] 0 0
Khon Kaen
Country [10] 0 0
Thailand
State/province [10] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Other
Name
Stephen Nicholls
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05325034
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Nicholls, MBBS, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julie Butters, BHSc, MBA
Address 0 0
Country 0 0
Phone 0 0
61 434679018
Fax 0 0
Email 0 0
julie.butters@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05325034