N/A
N=1,139
OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome.
Acute Coronary Syndrome · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT05844566 ↗Enrolled (actual)
1,139
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS — 369; 398; 145; 207 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Support System (DSS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS |
369; 398; 145; 207; 9; 11 | — |
| SECONDARY Timing of Initiation |
333; 367; 36; 31; 145; 207 | — |
| SECONDARY LDL-C Level |
57; 60 | — |
| SECONDARY Target LDL-C Reduction |
201; 184 | — |
Summary
The goal of this clinical trial is to compare implementation of a Decision Support System (DSS) - aligned to the 2019 ESC/EAS Guidelines - in addition to routine clinical care versus routine clinical care without availability of a DSS, in participants aged ≥18 to < 80 years old presenting with Acute Coronary Syndrome (ACS).
The main questions it aims to answer are:
* to assess whether the availability of a DSS (which provides estimates of risk and estimates of potential benefit through LDL-C lowering) to current practice results in an increase in the early initiation of combination Lipid Lowering Therapies (LLTs) or intensification of LLT regimens compared to current practice alone over a 16-week period after an Acute Coronary Syndromes (ACS) event
* To estimate in the study cohort the potential benefits of guideline-based LLT intensification via simulation-based methods using estimates of baseline risk: LLT utilisation, additional LDL-C reductions and LDL-C goal achievement, on simulated risk of CV events through modelling.
Participants will give consent to randomised clinical sites to collect their data. The clinical sites will either be randomised to standard of care or the availability of and access to the DSS.
Researchers will compare patients from DSS and Non-DSS sites to see if the availability of the DSS results in implementation of more intensive lipid lowering regimens, resulting in the achievement of lower LDL-C values as well as the proportion of patients who reach target LDL-C levels (<1.4 mmol/L (<55 mg/dL) by Week 16.
Eligibility Criteria
Inclusion criteria
Sites:
- Manage ACS patients as defined by: Symptoms of myocardial ischemia with an unstable pattern, occurring at rest or with minimal exertion, within 72 hours of an unscheduled hospital admission due to presumed or proven obstructive coronary disease and at least one of the following:
- Elevated cardiac biomarkers
- Resting electrocardiographic changes consistent with ischemia or infarction, plus additional evidence of obstructive coronary disease from regional wall motion or perfusion abnormality, 70% or more epicardial coronary stenosis by angiography, or need for coronary revascularization procedure
- Mange post ACS follow up care of patients including risk factor control
- Ability to provide follow up information on patient care for a minimum of 16 weeks including blood tests
- Willing/ able to access and undertake training for the DSS
- Adequate internet connection at site and the ability to access the DSS
- No restrictions on use of LLTs (within national guidelines/ reimbursement)
- Ability to include all essential parameters and patient information for DSS input
Participants:
- Aged ≥18 to < 80 years old
- Provide written informed consent
- Presenting to a study site with ACS as LLT naïve, monotherapy or combination therapy (defined as more than one LLT agent)
- Willing to take lipid lowering treatments for the secondary prevention of cardiovascular disease
- Attending the same study site (or same clinical team) for ACS follow up to ensure follow up data can be collected; or ensure that follow up data can be collected from other clinical institutions as part of the clinical pathway.
Exclusion criteria
Sites:
- Unable to capture/ provide data on patients with ACS during admission and follow up
- Unable or unwilling to use lipid lowering treatments other than statins for ACS care
Participants:
- Unable to provide written informed consent
- LDL-C measurement < 1.8 mmol/L at admission
Data sourced from ClinicalTrials.gov (NCT05844566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.