Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05844566
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-04-25
Brief Title:
OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZODIAC
Brief Summary:
The goal of this clinical trial is to compare implementation of a Decision Support System DSS - aligned to the 2019 ESCEAS 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 24-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 14 mmolL 55 mgdL by Week 24
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 24-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 14 mmolL 55 mgdL by Week 24
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 406007 patients over a median follow up of 378 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 14 mmolL 55 mgdL 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 5888 patients prescribed LLT in 18 European countries LDL-C goal achievement in very-high risk populations was just 39 per 2016 ESCEAS guidelines of18mmolL with only about 18 achieving the new recommended lower goal of 14mmolL 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 6 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
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 406007 patients over a median follow up of 378 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 14 mmolL 55 mgdL 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 5888 patients prescribed LLT in 18 European countries LDL-C goal achievement in very-high risk populations was just 39 per 2016 ESCEAS guidelines of18mmolL with only about 18 achieving the new recommended lower goal of 14mmolL 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 6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None