Clinical trial NCT05325034: Guideline Oriented Approach To Lipid Lowering In Asia-Pacific
Official title: Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Atherosclerosis
Hypercholesterolemia
Keywords: Acute Coronary Syndrome
Lipid management
Cholesterol
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2022-04-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients achieving an LDL <1.4mmol/L
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients who undergo intensification of lipid-lowering therapy
timeFrame: 6 months
measure: Proportion of patients prescribed high-intensity statin
timeFrame: 6 months
measure: Proportion of patients prescribed high-intensity statin at 6 months
timeFrame: 6 months
measure: Adherence to lipid lowering therapy
timeFrame: 6 months
measure: Patient activation and engagement in care
timeFrame: 6 months
measure: Proportion of patients achieving LDL<1.4mmol/L at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Wollongong
country: Australia
facility: Illawarra Shoalhaven Local Health District
state: New South Wales
city: Cairns
country: Australia
facility: Cairns & Hinterland Hospital & Health Service
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Osaka
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Pyeongchon
country: Korea, Republic of
facility: PyeongChon Hallym University Sacred Heart Hospital
state: Gyeonggi Province
city: Seoul
country: Korea, Republic of
facility: Kangnam Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Shah Alam
country: Malaysia
facility: University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
state: Selangor
city: Singapore
country: Singapore
facility: National Heart Centre
city: Singapore
country: Singapore
facility: National University Hospital Singapore (NUHS)
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
Study officials:
affiliation: Monash University
name: Stephen Nicholls, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: