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

NCT05844566 | Completed Results

• 1 other identifier: 22HH7982
• Study Type: interventional
• Target: 1,139
• Locations: 3 countries
• Sites: 42

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.

Conditions

Myocardial Infarction; Acute Coronary Syndrome

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

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (3)

• Timing of Initiation

  16 weeks

• LDL-C Level

  16 weeks

• Target LDL-C Reduction

  16 weeks

Study Arms (2)

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.

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.

Interventions

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.

Decision Support System (DSS)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Sanofi: collaborator
• Axtria, Inc.: collaborator
• Hospital Universitario La Paz: collaborator
• Hippocrates Research: collaborator

Study Sites (42)

AUSL di Bologna-Ospedale Maggiore

Bologna, 40133, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta

Caserta, 81100, Italy

Location

A.O.U. Ospedali Riuniti U.O.C. Cardiologia e UTIC

Foggia, 71122, Italy

Location

IRCCS. A.O.U. Policlinico San Martino IST

Genova, 16132, Italy

Location

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, 98125, Italy

Location

IRCCS Policlinico San Donato

Milan, 20097, Italy

Location

A.O.U Policlinico di Modena S.C. di Cardiologia

Modena, 41124, Italy

Location

Ospedale di Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria

Pisa, 56124, Italy

Location

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, 42121, Italy

Location

Ospedale Sandro Pertini - ASL Roma 2

Roma, 00157, Italy

Location

Azienda Ospedaliero Universitaria Santa Maria della Misericordia

Udine, 33100, Italy

Location

Hospital Clínico Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

University Hospital of A Coruña

A Coruña, Coruña, 15006, Spain

Location

Hospital HM Montepríncipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario La Luz Quiron

Madrid, 28003, Spain

Location

Gregorio Marañón General University Hospital

Madrid, 28007, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Puerta de Hierro Majadahonda University Hospital

Madrid, 28222, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Luton and Dunstable University Hospital

Luton, Bedfordshire, LU4 0DZ, United Kingdom

Location

Glan Glwyd Hospital

Bodelwyddan, Denbighshire, LL18 5UJ, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Conquest Hospital

Brighton, East Sussex, TN37 7PT, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, North Lincolnshire, DN15 7BH, United Kingdom

Location

Kettering General Hospital

Kettering, Northamptonshire, NN16 8UZ, United Kingdom

Location

Southern Health and Social Care Trust, Craigavon Area Hospital

Portadown, Northen Ireland, BT63 5QQ, United Kingdom

Location

Royal United Hospital

Bath, Somerset, BA1 3NG, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

North Tyneside General Hospital

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

Location

Sandwell General Hospital

Birmingham, West Midlands, B71 4HJ, United Kingdom

Location

Russell's Hall Hospital

Dudley, West Midlands, DY12HQ, United Kingdom

Location

Worthing Hospital

Worthing, West Sussex, BN11 2DH, United Kingdom

Location

Calderdale Royal Hospital

Halifax, West Yorkshire, HX3 0PW, United Kingdom

Location

Worcestershire Royal Hospital

Worcester, Worcestershire, WR5 1DD, United Kingdom

Location

Hammersmith Hospital

London, W2 1NY, United Kingdom

Location

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MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Prof. Kausik K Ray
• Organization: Imperial College London

k.ray@imperial.ac.uk

+44 7960 181 754

Study Officials

• Kausik Ray, Professor

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be notified at the end of the study in regard to allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised controlled trial. Study sites are randomised to intervention or no intervention.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: April 3, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (11); GB (17); ES (14)