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NCT05844566Completed

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

Implementation of a Decision Support System and Its Effect on Early Optimisation of Lipid-Lowering Therapies in Patients With Acute Coronary Syndrome: a Cluster Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
1139 (actual)
First submitted
25 Apr 2023
Start date
3 Apr 2023
Primary completion date
12 Dec 2024
Lead sponsor
Imperial College London
NCT number
NCT05844566

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1139
  • From 3 Apr 2023 to the primary completion date, 12 Dec 2024
  • 42 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • LDL-C measurement \< 1.8 mmol/L at admission

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of A Coruña
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A CoruñaSpainUnknown status
Vall d'Hebron University Hospital
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BarcelonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital HM Montepríncipe
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Boadilla del MonteSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
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El PalmarSpainUnknown status
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Universitario La Luz Quiron
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MadridSpainUnknown status
Puerta de Hierro Majadahonda University Hospital
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Gregorio Marañón General University Hospital
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MadridSpainUnknown status
Hospital Universitario Rey Juan Carlos
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MóstolesSpainUnknown status
Hospital Clinico Universitario Santiago de Compostela
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen Macarena
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SevilleSpainUnknown status
Royal United Hospital
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BathUnited KingdomUnknown status
Sandwell General Hospital
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BirminghamUnited KingdomUnknown status
Glan Glwyd Hospital
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BodelwyddanUnited KingdomUnknown status
Royal Bournemouth Hospital
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BournemouthUnited KingdomUnknown status
Conquest Hospital
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BrightonUnited KingdomUnknown status
Russell's Hall Hospital
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DudleyUnited KingdomUnknown status
Calderdale Royal Hospital
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HalifaxUnited KingdomUnknown status
Kettering General Hospital
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KetteringUnited KingdomUnknown status
Hammersmith Hospital
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LondonUnited KingdomUnknown status
Luton and Dunstable University Hospital
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LutonUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
North Tyneside General Hospital
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North ShieldsUnited KingdomUnknown status
Southern Health and Social Care Trust, Craigavon Area Hospital
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PortadownUnited KingdomUnknown status
Scunthorpe General Hospital
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ScunthorpeUnited KingdomUnknown status
Sunderland Royal Hospital
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SunderlandUnited KingdomUnknown status
Worcestershire Royal Hospital
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WorcesterUnited KingdomUnknown status
Worthing Hospital
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WorthingUnited KingdomUnknown status
AUSL di Bologna-Ospedale Maggiore
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BolognaItalyUnknown status
Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta
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CasertaItalyUnknown status
A.O.U. Ospedali Riuniti U.O.C. Cardiologia e UTIC
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FoggiaItalyUnknown status
IRCCS. A.O.U. Policlinico San Martino IST
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GenovaItalyUnknown status
Azienda Ospedaliera Universitaria Gaetano Martino
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MessinaItalyUnknown status
IRCCS Policlinico San donato
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MilanItalyUnknown status
A.O.U Policlinico di Modena S.C. di Cardiologia
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ModenaItalyUnknown status
Ospedale di Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria
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PisaItalyUnknown status
AUSL IRCCS di Reggio Emilia
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Reggio EmiliaItalyUnknown status
Ospedale Sandro Pertini - ASL Roma 2
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RomaItalyUnknown status
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
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UdineItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.