Guideline Oriented Approach to Lipid Lowering in Asia-Pacific (GOAL-ASIA)

Stephen Nicholls

Status: Enrolling

Conditions: Acute Coronary Syndrome; Hypercholesterolemia; Cardiovascular Diseases; Atherosclerosis

Treatments: Behavioral: Early Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05325034

APCMC-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,000 participants in 2 patient groups

Early intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Early Intervention

Late intervention

Other group

Description:

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

Treatment:

Behavioral: Early Intervention