Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stephen Nicholls
- Enrollment
- 2,000
- Locations
- 33
- Primary Endpoint
- Proportion of patients achieving an LDL <1.4mmol/L
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Proportion of patients prescribed high-intensity statin(6 months)
- Adherence to lipid lowering therapy(6 months)
- Patient activation and engagement in care(6 months)
- Proportion of patients achieving LDL<1.4mmol/L at 12 months(12 months)
- Proportion of patients who undergo intensification of lipid-lowering therapy(6 months)
- Proportion of patients prescribed high-intensity statin at 6 months(6 months)
Investigators
Stephen Nicholls
Professor
Monash University