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Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-09-15

    Primary completion: 2024-12-01

    Study completion finish: 2024-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05325034

    Intervention or treatment

    BEHAVIORAL: Early Intervention

    Conditions

    • Cardiovascular Diseases
    • Acute Coronary Syndrome
    • Atherosclerosis
    • Hypercholesterolemia
    Image related to Cardiovascular Diseases
    • Condition: Cardiovascular Diseases, Acute Coronary Syndrome and more

    • BEHAVIORAL: Early Intervention

    • Bedford Park, South Australia, Australia and more

    • Sponsor: Stephen Nicholls

    Find a site

    Closest Location:

    Flinders Medical Centre

    Research sites nearby

    Select from list below to view details:

    • Flinders Medical Centre

      Bedford Park, South Australia, Australia

    • Illawarra Shoalhaven Local Health District

      Wollongong, New South Wales, Australia

    • Cairns & Hinterland Hospital & Health Service

      Cairns, Queensland, Australia

    • Monash Health

      Clayton, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Proportion of patients achieving an LDL <1.4mmol/LProportion 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 outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Proportion of patients who undergo intensification of lipid-lowering therapyProportion of patients who undergo intensification of lipid-lowering therapy in 6 months6 months
    Proportion of patients prescribed high-intensity statinProportion of patients prescribed a guideline-recommended high-intensity statin through 6 months6 months
    Proportion of patients prescribed high-intensity statin at 6 monthsProportion of patients prescribed a guideline-recommended high-intensity statin at 6 months6 months
    Adherence to lipid lowering therapyProportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months6 months
    Patient activation and engagement in careLevel of patient activation and engagement in their care at 6 months compared with baseline6 months
    Proportion of patients achieving LDL<1.4mmol/L at 12 monthsProportion of patients achieving LDL\<1.4mmol/L at 12 months12 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

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