GOAL-ASIA: Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Sponsor

Stephen Nicholls (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05325034

Collaborator

Amgen (Industry)

2,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

133.3

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Acute Coronary Syndrome Atherosclerosis Hypercholesterolemia	Behavioral: Early Intervention	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	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 at the clinician's appointment and 4) currently prescribed lipid-lowering therapies.
Other: Late intervention Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group.	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 at the clinician's appointment and 4) currently prescribed lipid-lowering therapies.

Arm

Intervention/Treatment

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.

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 at the clinician's appointment and 4) currently prescribed lipid-lowering therapies.

Other: Late intervention

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

Behavioral: Early Intervention

Outcome Measures

Primary Outcome Measures

Proportion of patients achieving an LDL <1.4mmol/L [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Monash Health	Clayton	Victoria	Australia	3800
2	Fukuoka University Hospital	Fukuoka		Japan
3	Kyorin University Hospital	Mitaka		Japan
4	National Cerebral and Cardiovascular Center	Osaka		Japan
5	Osaka Medical and Pharmaceutical University Hospital	Osaka		Japan
6	PyeongChon Hallym University Sacred Heart Hospital	Pyeongchon	Gyeonggi Province	Korea, Republic of
7	Kangnam Hallym University Sacred Heart Hospital	Seoul		Korea, Republic of
8	Seoul St. Mary's Hospital	Seoul		Korea, Republic of
9	University Teknologi MARA, Hospital UiTM, UiTM Medical Centre	Shah Alam	Selangor	Malaysia
10	National Heart Centre	Singapore		Singapore
11	Ramathibodi Hospital	Bangkok		Thailand
12	Siriraj Hospital	Bangkok		Thailand
13	Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast	Khon Kaen		Thailand
14	Central Chest Institute, Nonthaburi, Thailand	Nonthaburi		Thailand
15	Songklanagarind Hospital	Songkhla		Thailand