Acute Coronary SyndromeZODIACNCT05844566
OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome.
A study testing Decision Support System (DSS) in people with Acute Coronary Syndrome and Myocardial Infarction, run by Imperial College London at 42 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Decision Support System (DSS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,139 participants
- Where
- 42 sitesin 3 countries
- Study dates
- 3 Apr 2023to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
42 sites in 3 countries.
42 sites in 3 countries
United Kingdom17 sites
Royal United Hospital
Bath, Somerset, BA1 3NG
Sandwell General Hospital
Birmingham, West Midlands, B71 4HJ
Glan Glwyd Hospital
Bodelwyddan, Denbighshire, LL18 5UJ
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
Conquest Hospital
Brighton, East Sussex, TN37 7PT
Russell's Hall Hospital
Dudley, West Midlands, DY12HQ
Calderdale Royal Hospital
Halifax, West Yorkshire, HX3 0PW
Kettering General Hospital
Kettering, Northamptonshire, NN16 8UZ
Hammersmith Hospital
London, W2 1NY
Luton and Dunstable University Hospital
Luton, Bedfordshire, LU4 0DZ
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
North Tyneside General Hospital
North Shields, Tyne and Wear, NE29 8NH
Southern Health and Social Care Trust, Craigavon Area Hospital
Portadown, Northen Ireland, BT63 5QQ
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, DN15 7BH
Sunderland Royal Hospital
Sunderland, Tyne and Wear, SR4 7TP
Worcestershire Royal Hospital
Worcester, Worcestershire, WR5 1DD
Worthing Hospital
Worthing, West Sussex, BN11 2DH
Spain14 sites
University Hospital of A Coruña
A Coruña, Coruña, 15006
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Vall d'Hebron University Hospital
Barcelona, 08035
Hospital HM Montepríncipe
Boadilla del Monte, Madrid, 28660
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario La Luz Quiron
Madrid, 28003
Gregorio Marañón General University Hospital
Madrid, 28007
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Puerta de Hierro Majadahonda University Hospital
Madrid, 28222
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
Hospital Clínico Universitario Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Hospital Universitario Virgen Macarena
Seville, 41009
Italy11 sites
AUSL di Bologna-Ospedale Maggiore
Bologna, 40133
Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta
Caserta, 81100
A.O.U. Ospedali Riuniti U.O.C. Cardiologia e UTIC
Foggia, 71122
IRCCS. A.O.U. Policlinico San Martino IST
Genova, 16132
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, 98125
IRCCS Policlinico San Donato
Milan, 20097
A.O.U Policlinico di Modena S.C. di Cardiologia
Modena, 41124
Ospedale di Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria
Pisa, 56124
AUSL-IRCCS di Reggio Emilia
Reggio Emilia, 42121
Ospedale Sandro Pertini - ASL Roma 2
Roma, 00157
Azienda Ospedaliero Universitaria Santa Maria della Misericordia
Udine, 33100
About this study
Official title: 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
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:
Read more
- 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- Decision Support System (DSS)
- Keywords
- Acute Coronary Syndrome, Decision Support System, Lipid Lowering Therapies, Low Density Lipoprotein, Heart Attack, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction, Coronary Disease
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support System (DSS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision Support System (DSS) | Other | 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. Receives: Device: Decision Support System (DSS) |
| Non-Decision Support System (Non-DSS) | No intervention | Patients of this cohort are seen at a site randomised to no availability of a DSS (Non-DSS). These patients will be provided routine clinical care including local / national prescribing guidelines during the course of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS
Proportion of patients treated with combination therapy, or who receive escalated monotherapy, or escalated combination therapy, within 16 weeks of the index ACS.
Measured: 16 weeks
Secondary outcomes (3)
Timing of Initiation
Timing of initiation of combination therapy or escalation of Lipid lowering therapy in those who met the primary endpoint.
Measured: 16 weeks
LDL-C Level
LDL-C by Week 16
Measured: 16 weeks
Target LDL-C Reduction
Proportion of patients reaching target LDL-C level (<1.4 mmol/L (<55 mg/dL) by Week 16
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start3 Apr 2023
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised controlled trial. Study sites are randomised to intervention or no intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Axtria, Inc., Hospital Universitario La Paz, Hippocrates Research
- Responsible party
- Sponsor
- Investigators
- Kausik Ray, Professor, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844566
- Sponsor's protocol ID
- 22HH7982
- Acronym
- ZODIAC
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2023
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schubert J, Lindahl B, Melhus H, Renlund H, Leosdottir M, Yari A, Ueda P, James S, Reading SR, Dluzniewski PJ, Hamer AW, Jernberg T, Hagstrom E. Low-density lipoprotein cholesterol reduction and statin intensity in myocardial infarction patients and major adverse outcomes: a Swedish nationwide cohort study. Eur Heart J. 2021 Jan 20;42(3):243-252. doi: 10.1093/eurheartj/ehaa1011.
PubMed 33367526Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
PubMed 30165516Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
PubMed 31504418Bohula EA, Morrow DA, Giugliano RP, Blazing MA, He P, Park JG, Murphy SA, White JA, Kesaniemi YA, Pedersen TR, Brady AJ, Mitchel Y, Cannon CP, Braunwald E. Atherothrombotic Risk Stratification and Ezetimibe for Secondary Prevention. J Am Coll Cardiol. 2017 Feb 28;69(8):911-921. doi: 10.1016/j.jacc.2016.11.070.
PubMed 28231942Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144.
PubMed 28444290Khan I, Peterson ED, Cannon CP, Sedita LE, Edelberg JM, Ray KK. Time-Dependent Cardiovascular Treatment Benefit Model for Lipid-Lowering Therapies. J Am Heart Assoc. 2020 Aug 4;9(15):e016506. doi: 10.1161/JAHA.120.016506. Epub 2020 Jul 28.
PubMed 32720582Ray KK, Reeskamp LF, Laufs U, Banach M, Mach F, Tokgozoglu LS, Connolly DL, Gerrits AJ, Stroes ESG, Masana L, Kastelein JJP. Combination lipid-lowering therapy as first-line strategy in very high-risk patients. Eur Heart J. 2022 Feb 22;43(8):830-833. doi: 10.1093/eurheartj/ehab718. No abstract available.
PubMed 34636884Ray KK, Molemans B, Schoonen WM, Giovas P, Bray S, Kiru G, Murphy J, Banach M, De Servi S, Gaita D, Gouni-Berthold I, Hovingh GK, Jozwiak JJ, Jukema JW, Kiss RG, Kownator S, Iversen HK, Maher V, Masana L, Parkhomenko A, Peeters A, Clifford P, Raslova K, Siostrzonek P, Romeo S, Tousoulis D, Vlachopoulos C, Vrablik M, Catapano AL, Poulter NR; DA VINCI study. EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. Eur J Prev Cardiol. 2021 Sep 20;28(11):1279-1289. doi: 10.1093/eurjpc/zwaa047.
PubMed 33580789Steen DL, Khan I, Ansell D, Sanchez RJ, Ray KK. Retrospective examination of lipid-lowering treatment patterns in a real-world high-risk cohort in the UK in 2014: comparison with the National Institute for Health and Care Excellence (NICE) 2014 lipid modification guidelines. BMJ Open. 2017 Feb 17;7(2):e013255. doi: 10.1136/bmjopen-2016-013255.
PubMed 28213597Ferrieres J, Gorcyca K, Iorga SR, Ansell D, Steen DL. Lipid-lowering Therapy and Goal Achievement in High-risk Patients From French General Practice. Clin Ther. 2018 Sep;40(9):1484-1495.e22. doi: 10.1016/j.clinthera.2018.07.008. Epub 2018 Aug 18.
PubMed 30126705Arca M, Ansell D, Averna M, Fanelli F, Gorcyca K, Iorga SR, Maggioni AP, Paizis G, Tomic R, Catapano AL. Statin utilization and lipid goal attainment in high or very-high cardiovascular risk patients: Insights from Italian general practice. Atherosclerosis. 2018 Apr;271:120-127. doi: 10.1016/j.atherosclerosis.2018.02.024. Epub 2018 Feb 17.
PubMed 29499359Blaum C, Seiffert M, Gossling A, Kroger F, Bay B, Lorenz T, Braetz J, Graef A, Zeller T, Schnabel R, Clemmensen P, Westermann D, Blankenberg S, Brunner FJ, Waldeyer C. The need for PCSK9 inhibitors and associated treatment costs according to the 2019 ESC dyslipidaemia guidelines vs. the risk-based allocation algorithm of the 2017 ESC consensus statement: a simulation study in a contemporary CAD cohort. Eur J Prev Cardiol. 2021 Mar 23;28(1):47-56. doi: 10.1093/eurjpc/zwaa088.
PubMed 33580772Marz W, Dippel FW, Theobald K, Gorcyca K, Iorga SR, Ansell D. Utilization of lipid-modifying therapy and low-density lipoprotein cholesterol goal attainment in patients at high and very-high cardiovascular risk: Real-world evidence from Germany. Atherosclerosis. 2018 Jan;268:99-107. doi: 10.1016/j.atherosclerosis.2017.11.020. Epub 2017 Nov 20.
PubMed 29197254Kuiper JG, Sanchez RJ, Houben E, Heintjes EM, Penning-van Beest FJA, Khan I, van Riemsdijk M, Herings RMC. Use of Lipid-modifying Therapy and LDL-C Goal Attainment in a High-Cardiovascular-Risk Population in the Netherlands. Clin Ther. 2017 Apr;39(4):819-827.e1. doi: 10.1016/j.clinthera.2017.03.001. Epub 2017 Mar 27.
PubMed 28347514Koskinas KC, Gencer B, Nanchen D, Branca M, Carballo D, Klingenberg R, Blum MR, Carballo S, Muller O, Matter CM, Luscher TF, Rodondi N, Heg D, Wilhelm M, Raber L, Mach F, Windecker S. Eligibility for PCSK9 inhibitors based on the 2019 ESC/EAS and 2018 ACC/AHA guidelines. Eur J Prev Cardiol. 2021 Mar 23;28(1):59-65. doi: 10.1177/2047487320940102. Epub 2020 Jul 20.
PubMed 33755142
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05844566
- Acronym / sponsor ID
- ZODIAC / 22HH7982
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, Decision Support System, Lipid Lowering Therapies, Low Density Lipoprotein, Heart Attack, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction, Coronary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,139 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Sanofi, Axtria, Inc., Hospital Universitario La Paz, Hippocrates Research
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 19 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomised controlled trial. Study sites are randomised to intervention or no intervention.
| Arm | Type | Receives |
|---|---|---|
| Decision Support System (DSS) | Other | Device: 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. |
| Non-Decision Support System (Non-DSS) | No intervention | –Patients of this cohort are seen at a site randomised to no availability of a DSS (Non-DSS). These patients will be provided routine clinical care including local / national prescribing guidelines during the course of the study. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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
Key exclusion criteria (6 listed)
- 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
- Unable to provide written informed consent
- LDL-C measurement < 1.8 mmol/L at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Decision Support System (DSS) |
Primary outcome
Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS
Time frame: 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.
3 secondary outcomes
Timing of Initiation
Time frame: 16 weeks
LDL-C Level
Time frame: 16 weeks
Target LDL-C Reduction
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33367526Schubert J, Lindahl B, Melhus H, Renlund H, Leosdottir M, Yari A, Ueda P, James S, Reading SR, Dluzniewski PJ, Hamer AW, Jernberg T, Hagstrom E. Low-density lipoprotein cholesterol reduction and statin intensity in myocardial infarction patients and major adverse outcomes: a Swedish nationwide cohort study. Eur Heart J. 2021 Jan 20;42(3):243-252. doi: 10.1093/eurheartj/ehaa1011.
- Background: PubMed 30165516Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
- Background: PubMed 31504418Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
- Background: PubMed 28231942Bohula EA, Morrow DA, Giugliano RP, Blazing MA, He P, Park JG, Murphy SA, White JA, Kesaniemi YA, Pedersen TR, Brady AJ, Mitchel Y, Cannon CP, Braunwald E. Atherothrombotic Risk Stratification and Ezetimibe for Secondary Prevention. J Am Coll Cardiol. 2017 Feb 28;69(8):911-921. doi: 10.1016/j.jacc.2016.11.070.
- Background: PubMed 28444290Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144.
- Background: PubMed 32720582Khan I, Peterson ED, Cannon CP, Sedita LE, Edelberg JM, Ray KK. Time-Dependent Cardiovascular Treatment Benefit Model for Lipid-Lowering Therapies. J Am Heart Assoc. 2020 Aug 4;9(15):e016506. doi: 10.1161/JAHA.120.016506. Epub 2020 Jul 28.
- Background: PubMed 34636884Ray KK, Reeskamp LF, Laufs U, Banach M, Mach F, Tokgozoglu LS, Connolly DL, Gerrits AJ, Stroes ESG, Masana L, Kastelein JJP. Combination lipid-lowering therapy as first-line strategy in very high-risk patients. Eur Heart J. 2022 Feb 22;43(8):830-833. doi: 10.1093/eurheartj/ehab718. No abstract available.
- Background: PubMed 33580789Ray KK, Molemans B, Schoonen WM, Giovas P, Bray S, Kiru G, Murphy J, Banach M, De Servi S, Gaita D, Gouni-Berthold I, Hovingh GK, Jozwiak JJ, Jukema JW, Kiss RG, Kownator S, Iversen HK, Maher V, Masana L, Parkhomenko A, Peeters A, Clifford P, Raslova K, Siostrzonek P, Romeo S, Tousoulis D, Vlachopoulos C, Vrablik M, Catapano AL, Poulter NR; DA VINCI study. EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. Eur J Prev Cardiol. 2021 Sep 20;28(11):1279-1289. doi: 10.1093/eurjpc/zwaa047.
- Background: PubMed 28213597Steen DL, Khan I, Ansell D, Sanchez RJ, Ray KK. Retrospective examination of lipid-lowering treatment patterns in a real-world high-risk cohort in the UK in 2014: comparison with the National Institute for Health and Care Excellence (NICE) 2014 lipid modification guidelines. BMJ Open. 2017 Feb 17;7(2):e013255. doi: 10.1136/bmjopen-2016-013255.
- Background: PubMed 30126705Ferrieres J, Gorcyca K, Iorga SR, Ansell D, Steen DL. Lipid-lowering Therapy and Goal Achievement in High-risk Patients From French General Practice. Clin Ther. 2018 Sep;40(9):1484-1495.e22. doi: 10.1016/j.clinthera.2018.07.008. Epub 2018 Aug 18.
- Background: PubMed 29499359Arca M, Ansell D, Averna M, Fanelli F, Gorcyca K, Iorga SR, Maggioni AP, Paizis G, Tomic R, Catapano AL. Statin utilization and lipid goal attainment in high or very-high cardiovascular risk patients: Insights from Italian general practice. Atherosclerosis. 2018 Apr;271:120-127. doi: 10.1016/j.atherosclerosis.2018.02.024. Epub 2018 Feb 17.
- Background: PubMed 33580772Blaum C, Seiffert M, Gossling A, Kroger F, Bay B, Lorenz T, Braetz J, Graef A, Zeller T, Schnabel R, Clemmensen P, Westermann D, Blankenberg S, Brunner FJ, Waldeyer C. The need for PCSK9 inhibitors and associated treatment costs according to the 2019 ESC dyslipidaemia guidelines vs. the risk-based allocation algorithm of the 2017 ESC consensus statement: a simulation study in a contemporary CAD cohort. Eur J Prev Cardiol. 2021 Mar 23;28(1):47-56. doi: 10.1093/eurjpc/zwaa088.
- Framework to aid in the creation of apps across multiple platforms including iOS, Android and Windows.Link provided by the sponsor.
- Angular is a development platform, built on TypeScript. This link can help you understand Angular: what Angular is, what advantages it provides, and what you might expect as you start to build applicationsLink provided by the sponsor.
- Empirical estimates of ICCs from changing professional practice studies. (Very small ICCs rounded to 0.0001; Negative ICCs truncated at zero; n/a = not applicable).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kausik Ray, Professor principal investigator
Imperial College London
42 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support System (DSS) in people with Acute Coronary Syndrome and Myocardial Infarction, run by Imperial College London at 42 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United Kingdom, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05844566, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.