This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effect of Evolocumab on Coronary Plaque Characteristics (NCT04710368), a na phase 4 study. The primary outcome is Change in Minimal Fibrous Cap Thickness (FCT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04710368 |
| Phase | Phase 4 |
| Condition | Coronary Artery Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 137 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Annapoorna Kini |
| Results posted | Yes |
2. Clinical Question
Population
The study description concerns patients with stable coronary artery disease receiving maximally tolerated statin therapy. The registry lists coronary artery disease as the condition and an enrollment of 137. Further eligibility criteria and the characteristics of the participants analyzed are not reported in the registry record.
Intervention
The intervention is evolocumab, described as subcutaneous administration of 140 mg every 2 weeks for 26 weeks. The study aims to assess plaque morphology using intravascular imaging and to examine peripheral blood mononuclear cell gene expression.
Comparator
The study is listed as single-group, with allocation recorded as NA and masking as none. A concurrent control group or randomized comparison is not described. The change over time is therefore the central comparison, rather than a contrast between treatment groups.
Primary question
The registry’s primary outcome measure is change in minimal fibrous cap thickness from baseline to 26 weeks, assessed by optical coherence tomography. The brief description also identifies change in maxLCBI4mm, measured by near-infrared spectroscopy, as a primary endpoint. Numerical results for either measure are not reported in the registry record, so the direction and precision of the observed changes cannot be assessed from this record.
3. Trial Design
This is a phase 4, single-group study listed as completed. The registry lists enrollment of 137, a start date of 2021-05-04, and a primary completion date of 2022-10-28. Those registry fields describe the study record; they do not establish how many participants completed follow-up or contributed data to each outcome. The number analyzed for each endpoint is not reported in the registry record.
Participants are described as having stable coronary artery disease while receiving maximally tolerated statin therapy. Evolocumab is described as a subcutaneous injection of 140 mg every 2 weeks for 26 weeks. The study combines intravascular imaging with gene-expression analysis of peripheral blood mononuclear cells. The stated purpose is to assess plaque morphology and explore molecular mechanisms associated with changes in atherosclerotic lesions.
The design matters for interpretation. With no concurrent control group described, the planned baseline-to-follow-up assessment can describe changes observed during the study period, but it cannot by itself separate a treatment-associated change from other explanations, such as time-related change, measurement variability, or changes in care. The record lists allocation as NA and masking as none; further details about how participants were selected or how outcome measurements were conducted are not reported in the registry record.
The primary outcome measure lists minimal fibrous cap thickness assessed by optical coherence tomography at baseline and 26 weeks. The brief study description additionally names maxLCBI4mm assessed by near-infrared spectroscopy as a primary endpoint. The registry lists 16 outcome measures and 0 analyses. Results for the listed imaging and gene-expression measures are not included in the record summarized by these registry entries. A protocol, a detailed statistical analysis plan, and the rationale for the enrollment target are not reported in the registry record.
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
| Stage | Treatment |
|---|---|
| STARTED | 137 |
| COMPLETED | 110 |
| NOT COMPLETED | 27 |
Reasons for not completing this period:
| Reason | Treatment |
|---|---|
| Withdrawal by Subject | 9 |
| Lost to Follow-up | 4 |
| Death | 2 |
| Patient preference | 11 |
| Treatment discontinuation | 1 |
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.
| Characteristic | Unit | Treatment |
|---|---|---|
| Participants analysed | 137 | |
| Age, Continuous | years | 66.0 (SD 9.7) |
| Sex: Female, Male: Female | Participants | 39 |
| Sex: Female, Male: Male | Participants | 98 |
| Race and Ethnicity Not Collected | Participants | — |
| Body Mass Index (BMI) | kg/m^2 | 31.6 (SD 19.3) |
| Hypertension | Participants | 127 |
| Previous Percutaneous coronary intervention (PCI) | Participants | 97 |
| Previous Myocardial Infarction (MI) | Participants | 32 |
| Current smoking | Participants | 14 |
| History of smoking | Participants | 51 |
| Diabetes | Participants | 74 |
| Baseline statin use: High intensity | Participants | 91 |
| Baseline statin use: Moderate intensity | Participants | 38 |
| Baseline statin use: Low intensity | Participants | 0 |
| Diseased Coronary Vessel Type: LAD - Left Anterior Descending Artery | Participants | 29 |
| Diseased Coronary Vessel Type: LCX - Left Circumflex Artery | Participants | 36 |
| Diseased Coronary Vessel Type: RCA - Right Coronary Artery | Participants | 70 |
| Diseased Coronary Vessel Type: RI - Ramus Intermedius Artery | Participants | 2 |
| Number of diseased vessels: 3 | Participants | 4 |
| Number of diseased vessels: 2 | Participants | 31 |
| Number of diseased vessels: 1 | Participants | 83 |
| Number of diseased vessels: 0 | Participants | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Minimal Fibrous Cap Thickness (FCT), measured over Baseline and 26 Weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | µm |
| Endpoint classification | Continuous Endpoint |
Minimal fibrous cap thickness is a measure of plaque morphology. The registry describes it as assessed by optical coherence tomography and measured in microns, with measurements at baseline and 26 weeks. The outcome is the change between those time points. A change in a continuous measure describes how far the measured value shifts, while its direction depends on the endpoint’s scale and the reported result.
In general, fibrous-cap measurements are used to characterize the structure of a coronary plaque. Optical coherence tomography provides the imaging method specified for this endpoint; the record does not give further details about the image acquisition or measurement procedure. Nor does it define a threshold for a clinically meaningful change.
The brief description names change in maxLCBI4mm by near-infrared spectroscopy as another primary endpoint, whereas the registry’s primary outcome measure presented in the record is minimal fibrous cap thickness. This distinction is important when interpreting the study’s planned outcomes. Neither endpoint’s numerical estimate, variability, confidence interval, or statistical test result is reported in the registry record. Consequently, the outcome definitions clarify what the study intended to measure, but do not establish the size, direction, or precision of any observed change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a study designed to measure plaque characteristics before and after a 26-week course of evolocumab. Its listed primary outcome is change in minimal fibrous cap thickness, and the brief description also identifies change in maxLCBI4mm as a primary endpoint. However, the record does not include numerical results for these outcomes. There is therefore no estimate in this record from which to describe the observed direction or magnitude of change, or how precisely either change was estimated.
That absence is central to interpretation. An endpoint definition is not an outcome result. Knowing that a measure was assessed at baseline and 26 weeks does not reveal whether values rose, fell, or remained similar. A result would ordinarily be interpreted alongside its estimate, an indication of variability or uncertainty, the number of participants contributing data, and any analysis method. These details are not reported in the registry record.
The single-group design also limits what a before-and-after observation could establish. In general, a within-group change can describe what happened over time among participants with measurements, but does not provide the same causal contrast as a concurrent control group. Without a like-for-like control, changes may reflect factors other than the intervention, including the passage of time and measurement variation. This is a design consideration, not a claim about what occurred in this study.
The record lists an enrollment of 137, but that figure does not establish the endpoint-specific analysis population. The number with baseline and follow-up imaging, reasons for missing measurements, and handling of missing data are not reported in the registry record. These details matter because results based on a subset of enrolled participants may describe that subset rather than everyone enrolled.
In general, a confidence interval conveys uncertainty around an estimate: narrower intervals indicate greater precision, while wider intervals indicate less precision. No confidence interval or other measure of endpoint precision is included in the registry record for this record. Likewise, no endpoint test statistic or p-value is reported, so statistical evidence against a specified null hypothesis cannot be assessed. The registry lists 0 analyses, and the analysis plan is not reported in the registry record.
Safety information is listed separately from the imaging outcomes. The record gives counts of serious events, other events, and deaths for a treatment group, along with percentages for two serious-event terms. The definitions, timing, event-level detail, and relationship of those counts to the outcome analysis are not reported. These data should not be used to fill the gap in the primary endpoint results or to infer a treatment effect.
9. Statistical Methods Explained
The registry record specifies outcome measures and a study design, but does not report a detailed statistical analysis plan. The explanations below are general statistical context for understanding the types of measurements described. They do not imply that a particular method was used in this study.
What does a change from baseline measure?
For a continuous endpoint, a change-from-baseline analysis compares a participant’s later measurement with that participant’s starting measurement. In general, an average change summarizes the direction and size of changes across participants with usable measurements. It is different from comparing the follow-up value alone, because the starting value is part of the definition. The registry lists baseline and 26 weeks for minimal fibrous cap thickness, but the numerical measurements and change estimate are not reported in the registry record.
With a single group, a change estimate describes the observed course in that group. It does not directly estimate the difference between what happened under treatment and what would have happened to the same participants without treatment. A concurrent comparison group can help address that question, subject to the design and analysis. No concurrent control group is described in this record. General interpretation of a before-and-after change should therefore distinguish description of change from a controlled estimate of causation.
Why do variability and precision matter?
Measurements vary across participants, and imaging measures can also be affected by how images are obtained and assessed. A mean change alone, if reported, would not show whether participants’ changes were similar or widely dispersed. A standard deviation describes variation among observations; a standard error or confidence interval instead communicates uncertainty in an estimated quantity. These concepts are related but not interchangeable. No endpoint estimate, standard deviation, standard error, or confidence interval is reported in the registry record, so precision cannot be assessed from these registry entries.
In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the analysis. Its interpretation depends on the chosen method and the data. A p-value addresses compatibility with a specified null model, but does not express the size or clinical relevance of an effect. Neither a confidence interval nor a p-value for the primary outcome is reported in this record. A result should not be inferred from the fact that an endpoint was designated primary.
What does the planning illustration represent?
The registry information describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. This is a planning exercise, not the trial’s own design justification: the study itself is listed as single-group, with allocation recorded as NA. The illustration’s numerical sample-size values and the fractions used are not reported in the registry record.
In general, a planning calculation estimates the sample size needed under stated assumptions. It is not an observed study result and does not show the probability that a finding from the completed study is true. A calculation based on an observed effect can also be sensitive to how that effect was estimated. The listed assumptions should therefore be read as properties of the planning illustration, not as proof that the original study was designed with two arms or that it followed those assumptions. No trial-specific sample-size justification is reported in the registry record.
How should multiple outcomes be considered?
The record lists 16 outcome measures, and the brief description identifies more than one primary endpoint. In general, when many outcomes or comparisons are examined, the chance of at least one apparently notable result can increase unless the analysis plan addresses multiplicity. Possible approaches depend on the study question and design. The record does not describe an adjustment strategy, a hierarchy of outcomes, or how the primary endpoints relate to the other listed measures. It is therefore not possible to determine how multiplicity was handled.
The record lists 0 analyses, and no statistical methods for the completed outcomes are described in the registry record. Whether analyses were adjusted for baseline values, covariates, or repeated measurements is not reported. No subgroup analysis plan, interim analysis plan, or protocol-based decision rule is reported in the registry record. Those omissions limit assessment of how the stated measures were translated into statistical tests or estimates.
What can be concluded from the listed design?
The study’s single-group structure makes the baseline-to-follow-up comparison descriptive unless additional design or analysis information establishes a stronger contrast. General statistical reasoning cannot substitute for missing endpoint estimates or a missing analysis plan. The methods and assumptions actually used for the imaging and gene-expression outcomes are not reported in the registry record. The record consequently supports describing the intended outcomes and design, but not reconstructing the study’s completed statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 16 outcome measures. The brief study description identifies minimal fibrous cap thickness and maxLCBI4mm as primary endpoints, while the primary outcome measure entry specifies minimal fibrous cap thickness. No hierarchy among outcomes, multiplicity adjustment, or prespecified strategy for interpreting multiple tests is reported in the registry record. In general, testing several outcomes can increase the chance of finding at least one result that appears notable by chance. Without an analysis plan, it is not possible to assess whether or how that issue was addressed.
Missing-data methods are also not reported. The record lists enrollment of 137, but does not specify how many participants had baseline and 26-week measurements for each endpoint, how many were missing, why measurements were missing, or whether any imputation or other method was used. The number analyzed for each outcome is not reported in the registry record. Thus, the enrollment figure cannot be treated as the denominator for every analysis.
The analysis population is not described. The record does not specify whether analyses were intended to include all enrolled participants, only those with follow-up measurements, or another defined group. It also does not describe exclusions, adherence criteria, or handling of participants who did not complete follow-up. The registry lists 0 analyses, and a statistical analysis plan is not reported in the registry record. These gaps prevent assessment of the analysis population, missingness, and multiplicity procedures.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Treatment | 5 | 110 | 4.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment | 2 of 110 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment | 30 of 110 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment |
|---|---|---|
| Urgent Revascularization | Cardiac disorders | 5 of 110 |
| Myocardial Infarction | Cardiac disorders | 1 of 110 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment |
|---|---|---|
| Chest pain/tightness | Cardiac disorders | 11 of 110 |
| Groin Pain | Vascular disorders | 5 of 110 |
| Shortness of breath | Cardiac disorders | 4 of 110 |
| Fatigue | Cardiac disorders | 4 of 110 |
| Back/feet pain | Metabolism and nutrition disorders | 3 of 110 |
| Cold/flu-like symptoms | Respiratory, thoracic and mediastinal disorders | 2 of 110 |
| Fever | Respiratory, thoracic and mediastinal disorders | 1 of 110 |
| Corneal abrasion | Eye disorders | 1 of 110 |
| Indigestion | Gastrointestinal disorders | 1 of 110 |
| COVID | Respiratory, thoracic and mediastinal disorders | 1 of 110 |
Serious events with the highest arm-level rate: urgent revascularization (4.5%), myocardial infarction (0.9%).
The registry lists 110 participants at risk in the treatment group, 5 with serious adverse events, 30 with other adverse events, and 2 deaths. It also lists Urgent Revascularization at 4.5% and Myocardial Infarction at 0.9% among the top serious-event terms. These figures are registry safety entries; the record does not provide further detail on event timing, individual participants, event counts by term, or the definitions used for the categories.
In general, a count of participants with an event is different from a count of events: one participant may experience more than one event. The registry record does not clarify the event-counting rules or whether the serious and other-event categories overlap. The percentages are quoted as listed; their denominator and calculation details are not reported in the registry record. The two deaths are listed, but their causes, timing, and relationship to treatment are not reported.
These safety figures describe what is recorded for this single group. Without a concurrent control group and additional context, they do not establish a comparative risk or explain whether events were caused by the intervention. They should be interpreted separately from the plaque imaging outcomes, for which numerical results are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The study record documents an investigation of evolocumab and coronary plaque characteristics using intravascular imaging and peripheral blood mononuclear cell gene-expression analysis. It describes a 26-week intervention and identifies change in minimal fibrous cap thickness as a primary outcome measure. The brief description also names maxLCBI4mm as a primary endpoint. These details explain the research question and intended measurements, but the numerical results for those endpoints are not reported in the registry record.
As a result, the record does not show the magnitude or direction of any change, its variability, or how precisely it was estimated. It also does not permit assessment of statistical significance for the primary outcomes. The absence of those results is not evidence that there was no change; it means that the change cannot be characterized from the information in this record.
Even if a before-and-after estimate were available, the listed single-group design would call for care in making causal claims. In general, observing change over time in a treated group does not show what would have occurred over that period without treatment. Other influences and measurement variation may contribute. The registry does not describe a concurrent control group, and the registry entries do not establish a controlled treatment effect.
The record also does not provide the analysis population, missing-data handling, or a detailed plan for the multiple outcomes. Those details affect how results would be interpreted and how broadly they apply. The safety entries provide counts and two percentages, but without further event definitions and a comparison group, they do not establish comparative safety.
The appropriate reading is therefore limited: the registry describes a completed single-group study, its intervention, and its intended imaging and molecular assessments, but the numerical primary outcome findings and important analysis details are not reported in the registry record. No conclusion about the size, precision, or cause of plaque changes can be drawn from these entries alone.
13. Why This Trial Matters Statistically
This study is statistically notable for combining continuous imaging outcomes with a single-group baseline-to-follow-up design. The registry defines minimal fibrous cap thickness as a continuous measure assessed by optical coherence tomography, with baseline and 26-week time points. The brief description adds maxLCBI4mm by near-infrared spectroscopy as a primary endpoint. This offers a clear example of why the outcome definition, measurement method, and analysis population all matter when interpreting a change over time.
The design also highlights the distinction between describing change and estimating a comparative effect. In general, repeated measurement can show whether a group’s values changed during follow-up, but a single group does not provide a concurrent counterfactual comparison. That limitation remains even when the outcome is measured in detail. The registry lists no like-for-like control group, so the design should not be read as a randomized comparison.
The record lists 16 outcome measures and 0 analyses. Without a reported hierarchy or multiplicity approach, readers cannot determine how the primary endpoints were prioritized relative to the other outcomes or how multiple statistical tests were handled. Nor can the enrollment entry of 137 substitute for endpoint-specific sample sizes. These are central issues for interpreting precision and the reliability of any estimates.
Finally, the record illustrates the difference between an endpoint plan and a result. It specifies clinically oriented imaging and molecular measures, but does not include the numerical primary outcome findings or their uncertainty. A statistical interpretation must remain tied to what the record actually reports, rather than treating a detailed study objective as evidence of an observed effect.
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 principal limitation for interpreting the findings is that numerical results for the primary imaging outcomes are not reported in the registry record. The primary outcome entry identifies change in minimal fibrous cap thickness, while the brief description also identifies maxLCBI4mm as a primary endpoint. No estimates, dispersion measures, confidence intervals, or test results for either measure are included in the registry record.
The study is listed as single-group, with allocation NA and masking none. No concurrent control group is described, limiting the ability of a before-and-after assessment to isolate changes associated with the intervention from other changes over time. Further details of imaging assessment, including measurement procedures and quality-control methods, are not reported in the registry record.
The registry lists enrollment of 137, but endpoint-specific participant counts and follow-up completeness are not reported. Eligibility criteria beyond the brief description, participant characteristics, reasons for missing measurements, and methods for handling missing data are also not reported. The analysis population and detailed statistical analysis plan are not reported in the registry record.
The record lists 16 outcome measures but does not describe a multiplicity strategy or outcome hierarchy. The planning illustration is based on an observed effect and assumptions for equal allocation between two arms, whereas the registered study is single-group; its numerical results and the fractions used are not reported in the registry record. No trial-specific sample-size justification is reported in the registry record. Safety entries lack detail on event timing, definitions, and denominator calculations.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Evolocumab on Coronary Plaque Characteristics — NCT04710368.
- Registry record last updated 2023-11-18; status last verified 2023-11.
- Results first posted 2023-05-03.
- 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.
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18. Record Summary
The registry record describes a completed phase 4, single-group study of evolocumab in patients with stable coronary artery disease on maximally tolerated statin therapy. It lists enrollment of 137, a start date of 2021-05-04, and a primary completion date of 2022-10-28. The intervention is subcutaneous evolocumab at 140 mg every 2 weeks for 26 weeks.
The primary outcome measure is change in minimal fibrous cap thickness by optical coherence tomography from baseline to 26 weeks. The brief description also identifies change in maxLCBI4mm by near-infrared spectroscopy as a primary endpoint. The registry lists 16 outcome measures and 0 analyses. Numerical primary outcome results, endpoint-specific analysis counts, missing-data methods, and the statistical analysis plan are not reported in the registry record.
Safety entries list 110 participants at risk, 5 with serious adverse events, 30 with other adverse events, and 2 deaths. Urgent Revascularization is listed at 4.5% and Myocardial Infarction at 0.9% among serious-event terms.