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OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome.

NCT05844566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1139

Last updated 2026-02-19

Study results available
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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.

Conditions

Interventions

DEVICE

Decision Support System (DSS)

This DSS will provide estimates of potential benefits in terms of ASCVD risk reduction (composite endpoint: combined non-fatal myocardial infarction, non-fatal ischaemic stroke and cardiovascular death) as a function of treatment duration and magnitude of LDL-C lowering. The DSS does not recommend treatments but shows the expected ASCVD risk, absolute and relative ASCDV risk reductions and number needed to treat for the various treatments selected by the clinical user on the potential value of initiation of an add-on therapy for reducing the risk of recurrent Cardiovascular (CV) events. Implementing the patient-specific recommendation remains at the clinicians' discretion.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Axtria, Inc.

    collaborator UNKNOWN

  • Hospital Universitario La Paz

    collaborator OTHER

  • Hippocrates Research

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Kausik Ray, Professor · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2024-12-12
Completion
2024-12-12

Countries

  • Italy
  • Spain
  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844566 on ClinicalTrials.gov