Trial Outcomes & Findings for OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome. (NCT NCT05844566)
NCT ID: NCT05844566
Last Updated: 2026-02-19
Results Overview
Proportion of patients treated with combination therapy, or who receive escalated monotherapy, or escalated combination therapy, within 16 weeks of the index ACS.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1139 participants
Primary outcome timeframe
16 weeks
Results posted on
2026-02-19
Participant Flow
Unit of analysis: Hospitals
Participant milestones
| Measure |
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.
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.
|
Non-Decision Support System (Non-DSS)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
523 19
|
616 23
|
|
Overall Study
COMPLETED
|
518 19
|
609 23
|
|
Overall Study
NOT COMPLETED
|
5 0
|
7 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome.
Baseline characteristics by cohort
| Measure |
Decision Support System (DSS)
n=523 Participants
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.
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.
|
Non-Decision Support System (Non-DSS)
n=616 Participants
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.
|
Total
n=1139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Spain
|
117 participants
n=4 Participants
|
172 participants
|
289 participants
n=4 Participants
|
|
Age, Continuous
|
62 Age in years
STANDARD_DEVIATION 10 • n=4 Participants
|
61 Age in years
STANDARD_DEVIATION 10
|
61 Age in years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=4 Participants
|
114 Participants
|
240 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
397 Participants
n=4 Participants
|
502 Participants
|
899 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
492 Participants
n=4 Participants
|
563 Participants
|
1055 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=4 Participants
|
5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
2 Participants
n=4 Participants
|
3 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=4 Participants
|
30 Participants
|
52 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
North African
|
1 Participants
n=4 Participants
|
4 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=4 Participants
|
11 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
252 participants
n=4 Participants
|
282 participants
|
534 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
154 participants
n=4 Participants
|
162 participants
|
316 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksProportion of patients treated with combination therapy, or who receive escalated monotherapy, or escalated combination therapy, within 16 weeks of the index ACS.
Outcome measures
| Measure |
Decision Support System (DSS)
n=523 Participants
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.
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.
|
Non-Decision Support System (Non-DSS)
n=616 Participants
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.
|
|---|---|---|
|
Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS
Primary outcome not met
|
145 Participants
|
207 Participants
|
|
Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS
Missing
|
9 Participants
|
11 Participants
|
|
Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS
Primary outcome met
|
369 Participants
|
398 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Planned analysis of the time to meet the primary endpoint was not performed because the majority of participants who met the primary outcome did so due to being prescribed combination therapy upon discharge. Escalation of treatment therefore occurred within a very short time frame (on the same day or within a few days of the index admission event). Formal time to event analysis was not considered meaningful. Instead we report here the timing of when participants met the primary endpoint.
Timing of initiation of combination therapy or escalation of Lipid lowering therapy in those who met the primary endpoint.
Outcome measures
| Measure |
Decision Support System (DSS)
n=523 Participants
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.
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.
|
Non-Decision Support System (Non-DSS)
n=616 Participants
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.
|
|---|---|---|
|
Timing of Initiation
Upon discharge
|
333 Participants
|
367 Participants
|
|
Timing of Initiation
During 4 month follow up
|
36 Participants
|
31 Participants
|
|
Timing of Initiation
Primary not met
|
145 Participants
|
207 Participants
|
|
Timing of Initiation
Missing
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Participants included if they have a baseline test result and at least one post-baseline test result available after Week 4; latest result used in the analysis, regardless of whether before or after Week 16.
LDL-C by Week 16
Outcome measures
| Measure |
Decision Support System (DSS)
n=367 Participants
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.
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.
|
Non-Decision Support System (Non-DSS)
n=366 Participants
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.
|
|---|---|---|
|
LDL-C Level
|
57 mg/dl
Standard Deviation 27
|
60 mg/dl
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Participants included if they have a baseline test result and at least one post-baseline test result available after Week 4; latest result used in the analysis, regardless of whether before or after Week 16
Proportion of patients reaching target LDL-C level (\<1.4 mmol/L (\<55 mg/dL) by Week 16
Outcome measures
| Measure |
Decision Support System (DSS)
n=367 Participants
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.
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.
|
Non-Decision Support System (Non-DSS)
n=366 Participants
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.
|
|---|---|---|
|
Target LDL-C Reduction
|
201 Participants
|
184 Participants
|
Adverse Events
Decision Support System (DSS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Decision Support System (Non-DSS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place