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

1. Trial at a Glance

This page covers the registry results for OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome. (NCT05844566), a randomized na study. The primary outcome is Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS.

2. Clinical Question

This distinction matters when interpreting the trial. The intervention was implemented at the clinical-site level, while the outcome was defined for participants. The clinical question is about a change in treatment decisions under the two care arrangements. It is not, on the information in the registry record, a direct comparison of cardiovascular events or of the clinical benefit of any individual lipid-lowering regimen. The trial summary also describes a separate aim to estimate potential benefits through simulation-based modelling; those simulated outcomes should be distinguished from observed trial outcomes.

3. Trial Design

The registry describes a randomised, parallel, single-masked trial with cluster allocation. Clinical sites, rather than individual participants, were assigned to make the decision support system available or to continue care without it. Participants consented to data collection at those sites. This design tests implementation in clinical practice: clinicians and patients at an assigned site encounter the care arrangement allocated to that site.

The registry lists an enrollment of 1139. It does not report the number of sites, how many sites were assigned to each group, or the number of participants contributing to the primary outcome in each group. It identifies the phase as not applicable. The recorded study dates are a start date of 2023-04-03 and a primary completion date of 2024-12-12; the overall status is completed.

The DSS group received routine care as well as access to the online system. The non-DSS group received routine care without DSS availability. The intervention description indicates that the DSS estimated risk and potential benefit from LDL-C lowering, but the registry record does not give a complete description of its operation or how clinicians used it. The masking designation is single, while the record does not identify which participants in the study were masked.

Cluster randomisation has implications for analysis. Participants treated at the same site may have more similar care or outcomes than participants at different sites. A suitable comparison generally needs to account for this within-site dependence; treating every participant as statistically independent can make uncertainty appear smaller than it is. The registry record does not report the statistical model, the handling of clustering, or the sponsor's primary analysis details. The trial description alone is not enough to reconstruct those methods or estimate the treatment effect.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS, measured over 16 weeks.

The primary endpoint is titled “Optimisation of the Intensity of Lipid Lowering Therapy Within 16 Weeks of Index ACS.” It measures the proportion of patients who, within that period, received combination therapy, had monotherapy escalated, or had combination therapy escalated. These alternatives define the qualifying treatment changes; the registry does not report the observed number or proportion meeting the endpoint.

As a general statistical concept, a treatment-process endpoint can capture whether care changed in the intended direction without waiting for a later clinical event. It is relevant to this trial because the intervention is a decision support system intended to inform treatment choices. It is not equivalent to an endpoint such as a cardiovascular event: it records a treatment action, not a health outcome. The registry separately lists LDL-C level, target LDL-C reduction, and timing of initiation as secondary outcomes, but detailed results for these outcomes are not reported in the registry record.

The endpoint combines several ways of intensifying therapy. This makes it a composite measure: a participant can qualify through any of the stated pathways. As a general consideration, a composite can summarise activity across related treatment changes, but the pathways may differ in clinical meaning and frequency. Without pathway-specific results, the overall endpoint cannot show which type of change contributed most. The registry describes the endpoint as a proportion and its unit as participants; it does not state the exact operational rules for classifying each pathway or how incomplete treatment records were handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomised, parallel, single-masked, cluster-randomised design. The unit of randomisation was the clinical site: sites were assigned to DSS availability or no DSS availability. Participants were then observed within those site-level care arrangements. This is different from individual randomisation, where each participant is assigned independently. The distinction is important because people treated at the same site can share clinicians, routines, and local practice. Their outcomes may therefore be more alike than outcomes from participants at different sites.

Why clustering affects the analysis

General statistical explanation: When observations within a cluster are correlated, the amount of independent information is less than the participant count alone might suggest. An analysis that assumes independence can produce confidence intervals that are too narrow and p-values that are too small. Cluster-aware approaches can account for this dependence, for example through models or standard errors that reflect site-level clustering. The registry record does not report which approach was used, how many sites took part, or any estimate of within-site correlation. It is therefore not possible to reproduce or assess the sponsor's handling of clustering from the record alone.

What the endpoint represents

The primary endpoint is a participant-level proportion defined by whether a qualifying treatment intensification occurred within 16 weeks of the index ACS. Its qualifying pathways are initiation of combination therapy, escalation of monotherapy, or escalation of combination therapy. In general, a proportion compares the number of participants meeting a defined condition with the number assessed for that outcome. Here, the registry does not report the group-specific counts, denominators used in the analysis, or the resulting proportions. It also does not describe the exact coding rules used to distinguish initiation from escalation.

Because the endpoint includes several pathways, it is a composite. General statistical explanation: A composite endpoint can capture multiple related ways an intervention may influence care. Its interpretation depends on the component definitions and on how often each component occurs. Without component-level results, the overall endpoint cannot reveal whether a difference, if any, arose mainly from starting combination treatment, increasing monotherapy, or increasing combination treatment. The registry record does not report these component-specific results.

Effect estimates and uncertainty

General statistical explanation: A treatment-effect estimate summarises the observed difference between groups on a chosen scale. A confidence interval describes the range of values compatible with the data and analysis under the method's assumptions; it communicates precision as well as direction. A p-value, when used, addresses how compatible the observed data are with a specified null model. None of these concepts substitutes for the estimate itself, and a p-value alone would not convey the magnitude or practical meaning of an effect. For this trial, the registry record does not report a primary effect estimate, confidence interval, or p-value.

The primary measure is described as a proportion, but the registry does not state whether the sponsor's comparison was reported as a difference, ratio, odds-based measure, or another scale. These scales answer related but not identical questions. Without the analysis result and its stated scale, the comparison cannot be reconstructed. No unadjusted re-calculation should be inferred from enrollment alone or from the safety counts.

Planning illustrations are not trial results

The page includes a sample-size section based on a planning illustration using the observed effect as a reference. The stated assumptions include a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial achieved a particular power. Sample-size illustrations are not observed power, and they do not replace the trial's result or its uncertainty interval. The registry record does not report the original design's sample-size justification, so the illustration should not be mistaken for the trial's own planning rationale.

Time-to-event planning tables, where present on the page, use total event counts under the stated Schoenfeld approach; other planning entries are expressed as participants per arm. These calculations are separate from the primary endpoint results. Since the primary endpoint is a treatment-process proportion and the registry record does not give its outcome counts, the planning section cannot establish what the trial observed.

What remains undocumented

The registry record does not report the sponsor's statistical analysis plan, the model used for the primary endpoint, any adjustment variables, handling of missing data, analysis populations, interim analyses, or multiplicity procedure. It also does not report whether the analysis followed the original site allocation for every participant or how site-level departures were addressed. These details matter because they can affect both the estimate and its uncertainty. In their absence, the appropriate reading is descriptive: the record shows a cluster-randomised comparison with a specified endpoint, but it does not expose enough of the analysis to independently verify an inferential result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, including the primary treatment-optimisation endpoint and secondary outcomes concerning timing of initiation, LDL-C level, and target LDL-C reduction. Considering multiple outcomes can raise a multiplicity issue: as a general statistical matter, the more comparisons examined, the greater the chance that at least one apparently notable result may arise by chance if no adjustment or prespecified hierarchy is used. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or adjusted results. No conclusion about how multiplicity was handled can be drawn from the outcome list alone.

The record also does not report whether interim analyses were planned or conducted. The sample-size assumptions displayed for the page are planning illustrations, not evidence of an interim monitoring plan or of the trial's original design justification. Any interim-analysis procedures are not reported in the registry record.

Missing-data methods and analysis populations are likewise not reported in the registry record. The available information does not specify how participants with incomplete treatment records were classified, what denominator was used for the primary proportion, or how missing LDL-C measurements were treated. It does not identify whether the primary comparison used all participants according to site assignment or a different analysis population. These omissions prevent assessment of how missingness or exclusions could affect the estimate.

For a cluster-randomised trial, the analysis population and treatment of site-level allocation are especially relevant. The registry does not state whether every participant was analysed under the site's assigned condition or how any departures from assignment were handled. No assumptions about these procedures should be inferred. In practical terms, the endpoint definitions and listed outcomes describe what the trial intended to examine, but the record does not document the analysis choices needed to judge multiplicity, missingness, or population selection.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry's adverse-event display lists 523 participants at risk in the DSS group and 616 in the non-DSS group for serious events and other events. It records zero affected participants in each of those displayed categories for both groups, and zero deaths in both groups. No serious-event terms are listed.

These entries should be read as the counts recorded in the registry display, not as proof that no adverse events occurred in the wider trial or that either care arrangement is free of risk. The record does not give further information about event definitions, collection procedures, reporting thresholds, follow-up completeness, or the time period covered by this safety display. It also does not explain whether the figures reflect all enrolled participants or a specific safety population beyond the at-risk counts shown.

As a general statistical point, a zero count is an observation within a reporting system and a defined population; it does not establish that the underlying event risk is exactly zero. The displayed figures are safety summaries and do not answer the primary question about treatment optimisation. Because no comparative analysis or uncertainty estimate for these safety counts is reported, the registry figures alone do not support a precise comparison of safety between groups.

12. What the Result Does, and Does Not, Mean

This trial was designed to examine whether making an online decision support system available at clinical sites was associated with greater optimisation of lipid-lowering therapy after ACS. The primary endpoint concerns treatment changes within 16 weeks, not cardiovascular events. The registry record explains what counted as optimisation but does not report the number or proportion of participants who met that definition in either group.

Accordingly, this record does not establish whether the DSS increased, decreased, or left unchanged the primary endpoint. It does not report an effect estimate or its precision, so the size of any difference is unknown from the posted information. The total enrollment of 1139 does not determine the outcome or tell readers how precise a group comparison would be, particularly in a cluster-randomised design where the site structure affects statistical information.

The trial summary also describes a planned modelling exercise to estimate potential cardiovascular benefits from guideline-based intensification. Such simulated outcomes, if reported elsewhere, would be model-based projections rather than observed cardiovascular outcomes in this trial. The registry record does not report those projections or the assumptions behind them. The primary endpoint should likewise not be interpreted as evidence that treatment changes caused a clinical benefit; it records care processes.

The safety display records zero affected participants and zero deaths in both groups, with the stated at-risk counts. Those are the recorded values, but the registry does not provide enough detail about event ascertainment or follow-up to interpret them as evidence of no risk. The absence of reported serious-event terms is also not a substitute for a complete safety analysis.

The most defensible conclusion is therefore limited: the registry documents a completed cluster-randomised trial, its care comparison, and its primary endpoint definition, but the outcome and analysis results are not reported in the registry record. Claims about the effectiveness, precision, or clinical consequences of the DSS require results beyond the information.

13. Why This Trial Matters Statistically

The trial raises a statistical question that is common in implementation research: how should an intervention delivered through clinical sites be evaluated when outcomes are measured for individual participants? Randomising sites can align the design with how a decision support system is introduced in routine practice. It also creates a dependence structure that must be represented in the analysis. The cluster design is not a minor detail; it affects how the data contribute information and how uncertainty should be calculated.

The endpoint also illustrates the distinction between a care process and a clinical outcome. Starting or intensifying lipid-lowering therapy is a measurable action that may be directly relevant to the intended role of a decision support tool. It does not, by itself, show whether cardiovascular health outcomes changed. The trial summary's separate modelling aim makes this distinction particularly important: observed treatment decisions and simulated benefits answer different questions.

There is also a measurement issue in combining several forms of intensification into one endpoint. A single overall proportion may be easy to communicate, but its meaning depends on the component pathways and their contributions. Component-level reporting would help readers understand what kind of care change the endpoint represents. The registry record does not report such details or the primary result.

Finally, a completed status does not itself make a result interpretable. Readers need outcome data, an analysis that accounts for site-level randomisation, and a description of uncertainty and missing-data handling. The registry gives the broad design and endpoint, but not these analysis results. Statistically, that gap limits what can be learned from the posted record, even though the trial question is clearly defined.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting this trial from the registry record is that the primary outcome result and its analysis are not reported. There are no group-specific endpoint counts or proportions, effect estimates, confidence intervals, or p-values in the information available for this page. The record therefore supports a description of the question and design, not an estimate of the effect of DSS availability.

Important design and analysis details are also absent. The registry does not report the number of clinical sites, their allocation, or the primary analysis model. Without these details, readers cannot assess how the analysis accounted for clustering or independently judge the precision of a participant-level comparison. The record does not describe the analysis population, treatment of participants with missing outcome information, handling of deviations from assigned site conditions, or covariate adjustment.

The primary endpoint groups distinct treatment changes together. The record does not provide component-specific results or complete operational rules for classifying each treatment pathway. This limits interpretation of what any overall endpoint difference would represent. Details of the DSS's full operation and implementation are also incomplete in the registry description, which ends mid-description.

The registry lists secondary outcomes but does not give their results or explain the multiplicity procedure. It also does not report whether interim analyses occurred or provide the original sample-size justification. The planning illustration on the page is not a substitute for that rationale or for observed results.

Safety information is limited to the displayed at-risk and affected counts, with no further description of ascertainment, follow-up, or event definitions. The trial's completed status and enrollment figure do not fill these gaps. These limitations are specific to what the registry record reports; they do not establish what may be available in other study materials.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome. — NCT05844566.
• Registry record last updated 2026-02-19; status last verified 2026-01.
• Results first posted 2026-02-19.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry identifies NCT05844566 as a completed, randomised, parallel, single-masked, cluster-randomised trial sponsored by Imperial College London. Enrollment was 1139. The recorded start date was 2023-04-03, and the primary completion date was 2024-12-12. The phase is listed as not applicable.

Clinical sites were assigned to routine care with access to an online DSS or routine care without DSS availability. The primary endpoint was the proportion of participants with qualifying lipid-lowering therapy initiation or escalation within 16 weeks of index ACS. The record also lists secondary outcomes relating to treatment timing, LDL-C level, and target LDL-C reduction.

The registry record does not report the primary outcome analysis, its effect estimate, or its precision. The safety display lists zero affected participants and zero deaths in each group, but does not include further event-collection details. The posted record therefore describes the study question and design without supplying the results needed to assess the primary comparison.