Guideline Oriented Approach to Lipid Lowering in Asia-Pacific
- Conditions
- HypercholesterolemiaCardiovascular DiseasesAcute Coronary SyndromeAtherosclerosis
- Interventions
- Behavioral: Early Intervention
- Registration Number
- NCT05325034
- Lead Sponsor
- Stephen Nicholls
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 18 years of age
- Admission for Type I myocardial infarction
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early intervention 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. Late intervention Early Intervention Those randomised to 'late' will receive standard-of-care and represent a control arm to the early intervention group.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Proportion of patients prescribed high-intensity statin 6 months Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months
Adherence to lipid lowering therapy 6 months Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months
Patient activation and engagement in care 6 months 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 12 months Proportion of patients achieving LDL\<1.4mmol/L at 12 months
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
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
Trial Locations
- Locations (18)
Illawarra Shoalhaven Local Health District
🇦🇺Wollongong, New South Wales, Australia
Cairns & Hinterland Hospital & Health Service
🇦🇺Cairns, Queensland, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Kyorin University Hospital
🇯🇵Mitaka, Japan
National Cerebral and Cardiovascular Center
🇯🇵Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Osaka, Japan
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, Korea, Republic of
University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
🇲🇾Shah Alam, Selangor, Malaysia
National Heart Centre
🇸🇬Singapore, Singapore
National University Hospital Singapore (NUHS)
🇸🇬Singapore, Singapore
Ramathibodi Hospital
🇹ðŸ‡Bangkok, Thailand
Siriraj Hospital
🇹ðŸ‡Bangkok, Thailand
Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
🇹ðŸ‡Khon Kaen, Thailand
Songklanagarind Hospital
🇹ðŸ‡Songkhla, Thailand