OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome.
- Conditions
- Acute Coronary SyndromeMyocardial Infarction
- Interventions
- Device: Decision Support System (DSS)
- Registration Number
- NCT05844566
- Lead Sponsor
- Imperial College London
- Brief 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.
- Detailed Description
Patients with acute coronary syndromes (ACS) including myocardial infarction (MI) remain at risk of future cardiovascular events depending upon the interaction between inherited genetic factors/ and environmental factors including cholesterol over their lifetime. Expert guidelines on secondary prevention such as the ESC therefore increasingly recognise a more individualised approach.
Lowering LDL-C with high intensity lipid lowering therapies (LLTs) initiated within 10 days of an ACS reduces risk more than less intense regimens. In the SWEDEHEART registry which included 40,6007 patients over a median follow up of 3.78 years, patients who achieved the largest absolute reductions in LDL-C or greatest percentage reduction in LDL-C, had the lowest risk of a range of cardiovascular events and mortality. The approach to use of lipid lowering (LLT) was statin based monotherapy with few attaining the recommended cholesterol goals.
The 2019 European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) dyslipidaemia guidelines categorise patients with an ACS event as very-high risk and recommend an LDL-C goal of \< 1.4 mmol/L (\<55 mg/dL) and \>50% reduction in LDL-C in this population. But several studies in European populations have highlighted gaps between clinical practice/ implementation of treatment recommendations compared with evidence based guideline recommendations. In the DA VINCI study representing 5,888 patients prescribed LLT in 18 European countries, LDL-C goal achievement in very-high risk populations was just 39% per 2016 ESC/EAS guidelines of\<1.8mmol/L with only about 18% achieving the new recommended lower goal of \<1.4mmol/L. It has become clear that greater implementation/ use of available combination therapies will be needed if lower recommended goals are to be achieved. It is unclear what the barriers are to earlier implementation and may include a lack of physician understanding of risk of further CV events or a lack of understanding of the quantifiable benefits from specific magnitudes of LDL-C lowering.
The aim of this trial is to assess whether providing information to those managing ACS patients that quantify absolute risk and the absolute benefit from different lipid lowering regimens through access to a Decision Support Tool (DSS) system is more likely to result in earlier intensification of lipid lowering regimens and thus result in a greater proportion of patients achieving the ESC lipid lowering goals after ACS compared to patients being managed routinely without access to a DSS standard (cluster RCT design). It is well established that unless treatments are initiated through secondary care or as part of acute care pathways, there is considerable inertia in further optimisation of treatment in primary care. Thus, this trial will assess whether presenting quantifiable data on risks and benefits results in behaviour change among secondary care physicians and improves cholesterol management within 4 months of an ACS.
The DSS is available online or remotely accessible via a website intended for clinicians to estimate the clinical benefit of any LLT regimen, whether single or combination therapies. The DSS shows the expected risk, 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 other Cardiovascular (CV) events. This DSS provides a graphical and tabular representation of the time-dependent CV treatment benefit model for LLTs published in a peer-reviewed journal article.
The trial hypothesises that having a pictorial representation of both individual risk and recommended treatments will encourage clinicians to implement clinical guidelines more closely. The clinicians using the DSS will be asked to complete a DSS evaluation at the end of the trial. Implementing the patient-specific recommendation remains at the clinicians' discretion.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1139
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision Support System (DSS) Decision Support System (DSS) Patients of this cohort are seen at a site randomised to the availability of the DSS. These patients will be provided routine clinical care including local/national prescribing guidelines during the course of the study. In addition to routine clinical care, the DSS which is available online, is a tool intended for clinicians to estimate the clinical benefit of any LLT regimen, whether monotherapy or combination therapies.
- Primary Outcome Measures
Name Time Method Optimisation of the intensity of Lipid Lowering Therapy within 16 weeks of index ACS 16 weeks Proportion of patients treated with combination therapy, or who receive escalated monotherapy, or escalated combination therapy, within 16 weeks of the index ACS.
- Secondary Outcome Measures
Name Time Method Time to initiation 16 weeks Time to initiation of combination therapy or escalation of Lipid lowering therapy as defined in the primary endpoint
LDL-C Level 16 weeks LDL-C by Week 16
Target LDL-C reduction 16 weeks Proportion of patients reaching target LDL-C level (\<1.4 mmol/L (\<55 mg/dL) by Week 16
Trial Locations
- Locations (42)
Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta
🇮🇹Caserta, Italy
A.O.U. Ospedali Riuniti U.O.C. Cardiologia e UTIC
🇮🇹Foggia, Italy
IRCCS. A.O.U. Policlinico San Martino IST
🇮🇹Genova, Italy
Azienda Ospedaliera Universitaria Gaetano Martino
🇮🇹Messina, Italy
IRCCS Policlinico San Donato
🇮🇹Milan, Italy
A.O.U Policlinico di Modena S.C. di Cardiologia
🇮🇹Modena, Italy
Ospedale di Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria
🇮🇹Pisa, Italy
AUSL-IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Hospital Clínico Universitario Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario La Luz Quiron
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena
🇪🇸Seville, Spain
Glan Glwyd Hospital
🇬🇧Bodelwyddan, Denbighshire, United Kingdom
Calderdale Royal Hospital
🇬🇧Halifax, West Yorkshire, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, Worcestershire, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
AUSL di Bologna-Ospedale Maggiore
🇮🇹Bologna, Italy
Ospedale Sandro Pertini - ASL Roma 2
🇮🇹Roma, Italy
Azienda Ospedaliero Universitaria Santa Maria della Misericordia
🇮🇹Udine, Italy
University Hospital of A Coruña
🇪🇸A Coruña, Coruña, Spain
Hospital HM Montepríncipe
🇪🇸Boadilla del Monte, Madrid, Spain
Puerta de Hierro Majadahonda University Hospital
🇪🇸Majadahona, Madrid, Spain
Hospital Universitario Rey Juan Carlos
🇪🇸Móstoles, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Gregorio Marañón General University Hospital
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Luton and Dunstable University Hospital
🇬🇧Luton, Bedfordshire, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, Dorset, United Kingdom
Conquest Hospital
🇬🇧Brighton, East Sussex, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, North Lincolnshire, United Kingdom
Kettering General Hospital
🇬🇧Kettering, Northamptonshire, United Kingdom
Southern Health and Social Care Trust, Craigavon Area Hospital
🇬🇧Portadown, Northen Ireland, United Kingdom
Royal United Hospital
🇬🇧Bath, Somerset, United Kingdom
Freeman Hospital
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
North Tyneside General Hospital
🇬🇧North Shields, Tyne And Wear, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, Tyne And Wear, United Kingdom
Sandwell General Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
Russell's Hall Hospital
🇬🇧Dudley, West Midlands, United Kingdom
Worthing Hospital
🇬🇧Worthing, West Sussex, United Kingdom