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

Primary Purpose

Cardiovascular Diseases, Acute Coronary Syndrome, Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Early Intervention
Sponsored by
Stephen Nicholls
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Acute Coronary Syndrome, Lipid management, Cholesterol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Illawarra Shoalhaven Local Health DistrictRecruiting
  • Cairns & Hinterland Hospital & Health ServiceRecruiting
  • Flinders Medical Centre
  • Monash HealthRecruiting
  • Fukuoka University Hospital
  • Kyorin University Hospital
  • National Cerebral and Cardiovascular CenterRecruiting
  • Osaka Medical and Pharmaceutical University Hospital
  • PyeongChon Hallym University Sacred Heart Hospital
  • Kangnam Hallym University Sacred Heart Hospital
  • Seoul St. Mary's Hospital
  • University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
  • National Heart CentreRecruiting
  • National University Hospital Singapore (NUHS)
  • Ramathibodi Hospital
  • Siriraj Hospital
  • Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
  • Songklanagarind Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Early intervention

Late intervention

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2022
Last Updated
June 6, 2023
Sponsor
Stephen Nicholls
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05325034
Brief Title
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific
Acronym
GOAL-ASIA
Official Title
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen Nicholls
Collaborators
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Acute Coronary Syndrome, Atherosclerosis, Hypercholesterolemia
Keywords
Acute Coronary Syndrome, Lipid management, Cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Late intervention
Arm Type
Other
Arm Description
Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Early Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients achieving an LDL <1.4mmol/L
Description
Proportion of patients achieving an LDL <1.4mmol/L at 6 months. This will be determined from values obtained through local laboratory testing.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of patients who undergo intensification of lipid-lowering therapy
Description
Proportion of patients who undergo intensification of lipid-lowering therapy in 6 months
Time Frame
6 months
Title
Proportion of patients prescribed high-intensity statin
Description
Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months
Time Frame
6 months
Title
Proportion of patients prescribed high-intensity statin at 6 months
Description
Proportion of patients prescribed a guideline-recommended high-intensity statin at 6 months
Time Frame
6 months
Title
Adherence to lipid lowering therapy
Description
Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months
Time Frame
6 months
Title
Patient activation and engagement in care
Description
Level of patient activation and engagement in their care at 6 months compared with baseline
Time Frame
6 months
Title
Proportion of patients achieving LDL<1.4mmol/L at 12 months
Description
Proportion of patients achieving LDL<1.4mmol/L at 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Butters, BHSc, MBA
Phone
61 434679018
Email
julie.butters@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Nicholls, MBBS, PhD
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illawarra Shoalhaven Local Health District
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Mackay
First Name & Middle Initial & Last Name & Degree
Astin Lee
Facility Name
Cairns & Hinterland Hospital & Health Service
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Dixon
First Name & Middle Initial & Last Name & Degree
Gregory Starmer
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Wollaston
First Name & Middle Initial & Last Name & Degree
Philip Aylward
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3800
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Butters
Email
julie.butters@monash.edu
First Name & Middle Initial & Last Name & Degree
Stephen Nicholls, MBBS
First Name & Middle Initial & Last Name & Degree
Adam Nelson, MBBS
Facility Name
Fukuoka University Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kohei Takata
First Name & Middle Initial & Last Name & Degree
Kohei Takata
Facility Name
Kyorin University Hospital
City
Mitaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sayaka Funabashi
First Name & Middle Initial & Last Name & Degree
Sayaka Funabashi
Facility Name
National Cerebral and Cardiovascular Center
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Kataoka
First Name & Middle Initial & Last Name & Degree
Yu Kataoka
First Name & Middle Initial & Last Name & Degree
Satoshi Honda
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Osaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daisuke Shishikura
First Name & Middle Initial & Last Name & Degree
Daisuke Shishikura
Facility Name
PyeongChon Hallym University Sacred Heart Hospital
City
Pyeongchon
State/Province
Gyeonggi Province
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Ho Jo
First Name & Middle Initial & Last Name & Degree
Sang-Ho Jo, MD
Facility Name
Kangnam Hallym University Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Rae Cho
First Name & Middle Initial & Last Name & Degree
Jung-Rae Cho, MD
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hun-Jun Park
First Name & Middle Initial & Last Name & Degree
Hun-Jun Park, MD
Facility Name
University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
City
Shah Alam
State/Province
Selangor
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sazzli Kasim
First Name & Middle Initial & Last Name & Degree
Sazzli Kasim
Facility Name
National Heart Centre
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khung Keong Yeo
First Name & Middle Initial & Last Name & Degree
Khung Keong Yeo
Facility Name
National University Hospital Singapore (NUHS)
City
Singapore
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sock-Hwee Tan
First Name & Middle Initial & Last Name & Degree
Mark Chan
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krissada Meemook
First Name & Middle Initial & Last Name & Degree
Krissada Meemook
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rungroj Krittayaphong
First Name & Middle Initial & Last Name & Degree
Rungroj Krittayaphong
Facility Name
Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
City
Khon Kaen
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burabha Pussadhamma
First Name & Middle Initial & Last Name & Degree
Burabha Pussadhamma
Facility Name
Songklanagarind Hospital
City
Songkhla
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ply Chichareon
First Name & Middle Initial & Last Name & Degree
Ply Chichareon

12. IPD Sharing Statement

Plan to Share IPD
No

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Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

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