Health TrialsbyHealthPanel

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

ConditionsCardiovascular DiseasesAcute Coronary SyndromeAtherosclerosisHypercholesterolemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStephen Nicholls

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age

Admission for Type I myocardial infarction

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Intervention

    Behavioral

    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.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Early interventionActive comparator 1 intervention
Group B: Late interventionOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

Proportion of patients who undergo intensification of lipid-lowering therapy

Proportion of patients who undergo intensification of lipid-lowering therapy in 6 months

Time frame
6 months
2

Proportion of patients prescribed high-intensity statin

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

Time frame
6 months
3

Proportion of patients prescribed high-intensity statin at 6 months

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

Time frame
6 months
4

Adherence to lipid lowering therapy

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stephen Nicholls

Lead sponsor

Monash University

Sponsor institution

Amgen

Collaborator

Source ClinicalTrials.gov
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