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
15
2
27
133.3
4.9

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
  • 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Proportion of patients prescribed high-intensity statin [6 months]

    Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months

  3. 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

  4. Adherence to lipid lowering therapy [6 months]

    Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months

  5. Patient activation and engagement in care [6 months]

    Level of patient activation and engagement in their care at 6 months compared with baseline

  6. 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:
No
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

Sponsors and Collaborators

  • Stephen Nicholls
  • Amgen

Investigators

  • Principal Investigator: Stephen Nicholls, MBBS, PhD, Monash University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephen Nicholls, Professor, Monash University
ClinicalTrials.gov Identifier:
NCT05325034
Other Study ID Numbers:
  • APCMC-1
First Posted:
Apr 13, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stephen Nicholls, Professor, Monash University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022