Acute Coronary Syndrome, Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia
Conditions
Keywords
Acute Coronary Syndrome, Lipid management, Cholesterol
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.
Interventions
BEHAVIORALEarly 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.
Sponsors
Amgen
Stephen Nicholls
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients prescribed high-intensity statin | 6 months | Proportion of patients prescribed a guideline-recommended high-intensity statin through 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 |
| 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 |
| 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 |
| Adherence to lipid lowering therapy | 6 months | Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months |
Countries
Australia, China, India, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand
Contacts
Primary ContactJulie Butters, BHSc, MBA
Outcome results
None listed