Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Study Overview
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Brief Summary
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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
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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.

Official Title
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Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)

Conditions
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Cardiovascular Diseases, Acute Coronary Syndrome, Atherosclerosis, Hypercholesterolemia

Intervention / Treatment
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* Behavioral: Early Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early intervention<br>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. | Behavioral: Early Intervention<br>* 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.<br>|
| Other: Late intervention<br>Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group. | Behavioral: Early Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who undergo intensification of lipid-lowering therapy | Proportion of patients who undergo intensification of lipid-lowering therapy in 6 months | 6 months | 
| Proportion of patients prescribed high-intensity statin | Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months | 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 | 6 months | 
| Adherence to lipid lowering therapy | Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months | 6 months | 
| Patient activation and engagement in care | Level of patient activation and engagement in their care at 6 months compared with baseline | 6 months | 
| Proportion of patients achieving LDL<1.4mmol/L at 12 months | Proportion of patients achieving LDL<1.4mmol/L at 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Lipid management, Cholesterol