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
- Diseases
- Coronary artery disease
- 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
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Vall d'Hebron University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital HM Montepríncipe Coordinator of this site? Confirm its status | Boadilla del Monte | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Luz Quiron Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Puerta de Hierro Majadahonda University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Gregorio Marañón General University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Rey Juan Carlos Coordinator of this site? Confirm its status | Móstoles | Spain | Unknown status |
| Hospital Clinico Universitario Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Royal United Hospital Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| Sandwell General Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Glan Glwyd Hospital Coordinator of this site? Confirm its status | Bodelwyddan | United Kingdom | Unknown status |
| Royal Bournemouth Hospital Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| Conquest Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Russell's Hall Hospital Coordinator of this site? Confirm its status | Dudley | United Kingdom | Unknown status |
| Calderdale Royal Hospital Coordinator of this site? Confirm its status | Halifax | United Kingdom | Unknown status |
| Kettering General Hospital Coordinator of this site? Confirm its status | Kettering | United Kingdom | Unknown status |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Luton and Dunstable University Hospital Coordinator of this site? Confirm its status | Luton | United Kingdom | Unknown status |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| North Tyneside General Hospital Coordinator of this site? Confirm its status | North Shields | United Kingdom | Unknown status |
| Southern Health and Social Care Trust, Craigavon Area Hospital Coordinator of this site? Confirm its status | Portadown | United Kingdom | Unknown status |
| Scunthorpe General Hospital Coordinator of this site? Confirm its status | Scunthorpe | United Kingdom | Unknown status |
| Sunderland Royal Hospital Coordinator of this site? Confirm its status | Sunderland | United Kingdom | Unknown status |
| Worcestershire Royal Hospital Coordinator of this site? Confirm its status | Worcester | United Kingdom | Unknown status |
| Worthing Hospital Coordinator of this site? Confirm its status | Worthing | United Kingdom | Unknown status |
| AUSL di Bologna-Ospedale Maggiore Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta Coordinator of this site? Confirm its status | Caserta | Italy | Unknown status |
| A.O.U. Ospedali Riuniti U.O.C. Cardiologia e UTIC Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| IRCCS. A.O.U. Policlinico San Martino IST Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Gaetano Martino Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| IRCCS Policlinico San donato Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| A.O.U Policlinico di Modena S.C. di Cardiologia Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Ospedale di Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| AUSL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Ospedale Sandro Pertini - ASL Roma 2 Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.