Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Cardiovascular Diseases Clinical Trial

— GOAL-ASIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325034
• Other study ID #: APCMC-1
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Monash University
• Contact: Julie Butters, BHSc, MBA
• Phone: 61 434679018
• Email: julie.butters[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Cardiovascular Diseases
• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Cairns & Hinterland Hospital & Health Service	Cairns	Queensland
Australia	Monash Health	Clayton	Victoria
Australia	Illawarra Shoalhaven Local Health District	Wollongong	New South Wales
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kyorin University Hospital	Mitaka
Japan	National Cerebral and Cardiovascular Center	Osaka
Japan	Osaka Medical and Pharmaceutical University Hospital	Osaka
Korea, Republic of	PyeongChon Hallym University Sacred Heart Hospital	Pyeongchon	Gyeonggi Province
Korea, Republic of	Kangnam Hallym University Sacred Heart Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Malaysia	University Teknologi MARA, Hospital UiTM, UiTM Medical Centre	Shah Alam	Selangor
Singapore	National Heart Centre	Singapore
Singapore	National University Hospital Singapore (NUHS)	Singapore
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast	Khon Kaen
Thailand	Songklanagarind Hospital	Songkhla

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Nicholls	Amgen

Countries where clinical trial is conducted

Australia,  Japan,  Korea, Republic of,  Malaysia,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of patients prescribed high-intensity statin	Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months	6 months
Secondary	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
Secondary	Adherence to lipid lowering therapy	Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months	6 months
Secondary	Patient activation and engagement in care	Level of patient activation and engagement in their care at 6 months compared with baseline	6 months
Secondary	Proportion of patients achieving LDL<1.4mmol/L at 12 months	Proportion of patients achieving LDL<1.4mmol/L at 12 months	12 months