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 Polypill in Acute Coronary Syndrome (NCT05514938), a randomized phase 2 study. The primary outcome is Low Density Lipoprotein - Cholesterol.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05514938 |
| Phase | Phase 2 |
| Condition | Acute Coronary Syndrome, Lipid Disorder, Coronary Artery Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 140 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with acute coronary syndrome or high-risk PCI in an underserved patient population. The primary analysis includes participants who completed the 1-month study visit with an LDL-C measurement. The registry record reports an enrollment of 140, but does not give further details about the characteristics of the analyzed participants or how many eligible participants lacked a 1-month LDL-C result.
Intervention
The strategy is a fixed-dose, once-daily polypill alongside other guideline-directed medical therapies prescribed by the participant’s physician. The pill combines rosuvastatin 40 mg and aspirin 81 mg with either clopidogrel 75 mg or prasugrel 10 mg daily. The registry record does not report how the choice between the two antiplatelet medicines was made.
Comparator
The comparison is usual post-ACS care, with individual medications prescribed by the participant’s primary cardiologist or provider. The registry description says the individual components were available to participants at low or no cost. The comparison therefore concerns a medication-delivery strategy, not simply whether the component medicines were prescribed.
Primary question
At 1 month, how did the baseline-adjusted change in low-density lipoprotein cholesterol differ between the polypill strategy and usual care? LDL-C is reported in mg/dL. The registry reports least-squares mean changes within each group and a between-group mean difference (net), with a 95% confidence interval and p-value.
3. Trial Design
NCT05514938, titled “Polypill in Acute Coronary Syndrome,” is a phase 2, randomized, parallel-group trial. The registry record lists the study as completed, with an enrollment of 140. The listed start date is 2022-11-30 and the primary completion date is 2025-05-30. The sponsor is the University of Texas Southwestern Medical Center.
Participants were assigned to a polypill strategy or usual care. The trial is listed as having no masking, so it was open label. In the polypill group, the fixed-dose combination included rosuvastatin 40 mg, aspirin 81 mg, and either prasugrel 10 mg or clopidogrel 75 mg daily. Participants also received other guideline-directed medical therapies prescribed by their physician. In the usual-care group, the individual medications were prescribed by the participant’s provider.
The primary outcome was LDL-C at the 1-month visit, assessed as change from baseline. The primary population is defined as participants who completed the 1-month study visit with LDL-C. The registry describes least-squares means from linear regression models adjusted for baseline values. It reports group-specific estimates and a between-group difference for polypill versus usual care.
Other listed outcomes include self-reported adherence, treatment satisfaction, and quality of life at 1 month. The registry record does not report the detailed allocation procedure, the blinding of laboratory measurement, or a full protocol description. The basis for choosing the study enrollment target and any planned interim analyses 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.
Before assignment: All enrolled participants were randomized.
Overall Study
| Stage | Polypill | Usual Care (Individual Medications Prescribed by Primary Cardiologist) |
|---|---|---|
| STARTED | 69 | 71 |
| COMPLETED | 65 | 63 |
| NOT COMPLETED | 4 | 8 |
Analysis population for the primary outcome, as defined in the registry: Participants who completed the 1-month study visit with LDL-C
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 | Polypill | Usual Care (Individual Medications Prescribed by Primary Cardiologist) | Total |
|---|---|---|---|---|
| Participants analysed | 69 | 71 | 140 | |
| Age, Continuous | years | 55 (50 to 62) | 61 (53 to 67) | 58 (51 to 64) |
| Sex: Female, Male: Female | Participants | 21 | 20 | 41 |
| Sex: Female, Male: Male | Participants | 48 | 51 | 99 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 41 | 47 | 88 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 28 | 24 | 52 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 4 | 5 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 12 | 8 | 20 |
| Race (NIH/OMB): White | Participants | 55 | 59 | 114 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| P2Y12 Inhibitor at randomization: Prasugrel | Participants | 44 | 42 | 86 |
| P2Y12 Inhibitor at randomization: Clopidogrel | Participants | 25 | 29 | 54 |
6. Primary Endpoint
The registry lists the primary outcome as Low Density Lipoprotein - Cholesterol, measured over 1 month.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
Low-density lipoprotein cholesterol (LDL-C) is a continuous laboratory measure, reported in mg/dL. The primary endpoint concerns change from baseline to the 1-month visit. The registry reports a least-squares mean change for each group and a between-group mean difference (net) comparing the polypill strategy with usual care. The group estimates come from linear regression models adjusted for baseline values.
Change from baseline captures how the measured LDL-C value at follow-up differs from the participant’s baseline value. Comparing changes between randomized groups can describe whether the groups followed different average trajectories during the study period. Baseline adjustment is a way to account statistically for the starting measurement when estimating the follow-up comparison. A least-squares mean is a model-based group estimate, rather than a simple unadjusted average.
LDL-C is relevant to this study because the polypill includes a high-intensity statin, rosuvastatin 40 mg daily. However, an endpoint’s biological relevance does not by itself establish what the study result means clinically. The reported outcome is limited to LDL-C at the 1-month visit among participants with a recorded value who completed that visit. The registry record does not report longer-term LDL-C results in the primary outcome or a clinical-event endpoint as the primary measure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a least-squares mean LDL-C change of -6.74 mg/dL in the polypill group, with a 95% confidence interval from -12.03 to -1.46. For usual care, the corresponding estimate is 0.53 mg/dL, with a 95% confidence interval from -6.75 to 7.81. These are baseline-adjusted group estimates for participants with a 1-month LDL-C result.
The reported between-group mean difference (net), polypill versus usual care, is -4.58 mg/dL. Its 95% confidence interval ranges from -12.68 to 3.52 mg/dL, and the reported p-value is 0.27. The point estimate is negative, indicating a lower estimated change in the polypill group relative to usual care under the stated comparison. The confidence interval includes zero, so the posted estimate is compatible with a range of between-group differences that includes no difference as well as differences in either direction.
A confidence interval describes the statistical uncertainty around an estimate under the analysis assumptions. It should not be read as a range containing a fixed proportion of individual participants’ outcomes. The interval for the between-group estimate is relatively broad compared with the point estimate, so the registry result does not pin down the size or direction of the underlying between-group difference precisely. The p-value of 0.27 is the value reported for the sponsor’s linear regression comparison; it is not a measure of the probability that the null hypothesis is true.
The group-specific intervals also matter. The polypill estimate’s interval is below zero, whereas the usual-care interval includes zero. That contrast between group-specific intervals is not itself the formal test of the difference between groups. The between-group confidence interval and its p-value are the relevant posted statistics for the comparative question. Because the between-group interval crosses zero, the estimates do not establish a clear separation between strategies in the primary outcome.
These results describe the measured one-month LDL-C outcome in the registry’s primary analysis population. They do not establish whether the polypill strategy changes adherence, clinical events, or longer-term outcomes. Adherence, treatment satisfaction, and quality of life are listed as secondary outcomes, but their results are not included in the registry record described for this analysis. The posted primary result should therefore be interpreted as an uncertain estimate of a short-term laboratory difference, not as a conclusion about all effects of the strategy.
9. Statistical Methods Explained
What does the primary estimate represent?
The endpoint is continuous: LDL-C is measured on a numeric scale in mg/dL. The registry reports least-squares mean changes from baseline for each group. These are estimates from linear regression models that adjust for baseline LDL-C. The model-based estimates may differ from raw group averages because the regression accounts for baseline values. The registry record does not report the complete model specification, including any additional covariates or diagnostics.
The between-group mean difference (net) is the model’s comparison of change in the polypill group with change in usual care. The reported value is -4.58 mg/dL. In a comparative trial, the between-group estimate is generally more informative for the treatment-strategy contrast than a comparison of whether each group’s change differs from zero. A change in one group alone does not show that the groups differ.
How should the confidence interval be read?
The 95% confidence interval for the reported difference extends from -12.68 to 3.52 mg/dL. In general, a confidence interval expresses uncertainty around an estimate using the assumptions of the statistical method. It gives a range of values compatible with the data and model at the stated confidence level; it does not describe the spread of individual LDL-C measurements.
Here the interval spans zero. That means the posted data and model do not exclude a zero between-group difference at this confidence level. The interval also includes negative and positive values, so the result leaves uncertainty about both the magnitude and direction of the contrast. The width of an interval reflects precision as well as the scale of the estimate: a wider interval indicates less precision. Confidence intervals should be considered alongside the point estimate and the endpoint’s units, rather than reduced to a binary finding.
What does the p-value contribute?
The registry reports p = 0.27 for the linear regression comparison. In general, a p-value measures how incompatible the observed data are with a specified null model, under the assumptions of the analysis. It is not the probability that there is no effect, and it does not quantify the chance that the observed estimate is due to chance. Nor does it describe clinical importance. The confidence interval and point estimate provide information about plausible values and precision that a p-value alone cannot convey.
The reported p-value pertains to the sponsor’s stated primary comparison. The registry record does not report a complete statistical analysis plan, including the full hypothesis-testing framework, model diagnostics, or any prespecified thresholds for interpretation. No additional assumptions about those details can be made from the registry entry.
Why adjust for baseline?
Baseline adjustment uses participants’ starting LDL-C values in the regression model for the follow-up comparison. As a general statistical approach, adjustment can improve precision when baseline values are related to follow-up values and can account for chance differences in starting measurements. It does not remove all uncertainty, and it relies on the model being a reasonable representation of the data. The registry identifies baseline adjustment but does not report enough detail to assess the model’s assumptions independently.
Randomization is intended to support a fair comparison of assigned strategies by reducing systematic differences between groups at allocation. It does not ensure that every measured or unmeasured characteristic is exactly balanced, particularly in a phase 2 study. The registry record gives the randomized parallel-group design but does not describe the sequence-generation or allocation-concealment procedures.
Which population does the estimate address?
The primary outcome population is defined as participants who completed the 1-month visit with LDL-C. This is a visit-completer, measurement-based population definition. It is not, on its face, a statement that every randomized participant contributed to the primary analysis. The registry record does not report the handling of missing 1-month values, the number of participants excluded from the primary analysis for missing LDL-C, or whether imputation or another missing-data method was used.
In general, restricting an analysis to participants with observed follow-up measurements can affect interpretation if the likelihood of having a measurement is related to group assignment or outcome. Without details about missingness and analysis procedures, the extent of any such effect cannot be assessed from this record.
What can be inferred from the posted comparison?
The primary estimate is a model-based comparison of average changes, not a comparison of every individual’s response. Continuous outcomes can vary substantially across participants, and a group mean does not show the full distribution. The registry record does not report the standard deviation or other individual-level spread for this endpoint. It does report confidence intervals for the model estimates, which represent uncertainty in those estimates rather than participant-to-participant variability.
General planning calculations based on an observed effect are illustrative, not evidence of the power achieved in the completed trial. The registry record does not report the original sample-size justification or its design assumptions. No conclusion about observed power or the adequacy of the original target can be drawn from the primary result alone.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Regression, Linear | Mean Difference (Net) -4.58 | -12.68 to 3.52 | 0.270 |
The registry’s primary comparison is a linear regression analysis reported as a mean difference (net) for polypill versus usual care. It gives an estimate of -4.58 mg/dL, a 95% confidence interval from -12.68 to 3.52 mg/dL, and p = 0.27. This is the sponsor-reported inferential result to use when describing the trial’s primary comparison.
The registry also reports adjusted least-squares mean changes within each group. Those group estimates are not a substitute for the between-group comparison: the central question is whether the groups differ, rather than whether either group’s own change is distinguishable from zero. The confidence interval for the reported net difference includes zero, and the p-value is the sponsor’s reported test for that comparison.
The registry record does not provide a separate unadjusted recalculated estimate for the primary comparison in the registry record for this explanation. It is therefore not possible to give a numerical comparison between the sponsor’s model-based result and a separate recalculation. The sponsor’s stated method and reported estimate remain the relevant posted analysis, with its interpretation limited by the uncertainty.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and five analyses, and identifies self-reported adherence, treatment satisfaction, and quality of life at 1 month as secondary outcomes. The primary endpoint is LDL-C at 1 month. The results described for the primary analysis do not include the findings for those secondary outcomes, so their direction, magnitude, and precision cannot be assessed from this record.
When a study evaluates multiple outcomes or makes multiple statistical comparisons, the chance of at least one apparently notable result can increase. General methods for addressing multiplicity include prespecifying a primary outcome, adjusting inferential thresholds, or treating additional analyses as exploratory. The registry record does not report whether or how multiplicity was addressed, whether secondary outcomes were prespecified in a detailed analysis plan, or how the five analyses relate to the listed measures. The primary p-value should not be treated as though it automatically accounts for all analyses.
The primary analysis population is participants who completed the 1-month study visit with LDL-C. The registry record does not report the amount or pattern of missing primary outcome data, reasons for missingness, or the method used to handle missing measurements. It does not report whether analyses were conducted according to randomized assignment for all participants or whether other analysis populations were used. These details matter because an analysis limited to observed visit completers may differ in interpretation from an analysis of all randomized participants.
The registry record also does not report a protocol-level statistical analysis plan, a missing-data sensitivity analysis, or a sample-size justification. These are not details that can be inferred from the reported confidence interval and p-value. The reported result should therefore be read as applying to the stated primary population and sponsor analysis, while recognizing that the record leaves important analysis details unreported.
12. 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 |
|---|---|---|---|
| Polypill | 8 | 69 | 11.6% |
| Usual Care (Individual Medications Prescribed by Primary Cardiologist) | 8 | 71 | 11.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Polypill | 0 of 69 |
| Usual Care (Individual Medications Prescribed by Primary Cardiologist) | 0 of 71 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0.7% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Polypill | 0 of 69 |
| Usual Care (Individual Medications Prescribed by Primary Cardiologist) | 1 of 71 |
Most frequent serious adverse event terms
| Event term | Organ system | Polypill | Usual Care (Individual Medications Prescribed by Primary Cardiologist) |
|---|---|---|---|
| Total Hospitalizations and Emergency Department Visits | Blood and lymphatic system disorders | 8 of 69 | 8 of 71 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Polypill | Usual Care (Individual Medications Prescribed by Primary Cardiologist) |
|---|---|---|---|
| Non-elective percutaneous coronary intervention | Cardiac disorders | 0 of 69 | 1 of 71 |
Serious events with the highest arm-level rate: total hospitalizations and emergency department visits (11.6%).
The adverse-event record lists serious adverse events affecting 8 participants in the polypill group and 8 participants in the usual-care group. It lists other adverse events affecting 0 participants in the polypill group and 1 participant in the usual-care group. Deaths are listed as 0 in each group. These counts are descriptive registry entries and do not, by themselves, establish a comparative safety difference.
The record lists “Total Hospitalizations and Emergency Department Visits” as the leading serious-event term, with 11.6%. The registry entries do not explain the denominator for that percentage or how the term relates to the participant-level serious adverse-event counts. A serious-event count and an event-term percentage may represent different reporting units, so they should not be treated as interchangeable or added together.
These figures do not show the timing, duration, severity breakdown, or causal attribution of events. The record also does not report a statistical comparison of adverse events. In general, safety counts require context about exposure, follow-up, event definitions, and the number of events as well as the number of affected participants. The listed counts should be read as the posted observations, not as proof that risks are equal or different.
13. What the Result Does, and Does Not, Mean
The primary result is an estimate of the difference in baseline-adjusted LDL-C change at 1 month between the polypill strategy and usual care. The estimated difference is -4.58 mg/dL, with a 95% confidence interval from -12.68 to 3.52 mg/dL and p = 0.27. The interval includes zero and covers values on both sides of zero, leaving uncertainty about the direction and size of the between-group contrast.
This result does not demonstrate a clear between-group difference in the primary endpoint. It also does not establish that the groups are equivalent. A finding that does not clearly separate the groups is not the same as evidence that any difference is absent or negligible. Assessing equivalence or non-inferiority would require an appropriate design and prespecified margins, which are not reported in the registry record.
The outcome is a laboratory measure at the 1-month visit, not a direct measure of heart attacks, survival, hospitalization, adherence, or quality of life. The study description lists some of those domains as secondary outcomes, but their results are not included in the analysis details. The primary result cannot stand in for those outcomes or establish the longer-term consequences of either medication strategy.
Interpretation is also bounded by the primary population definition: participants who completed the 1-month visit with LDL-C. The registry record does not provide enough information to assess missing-data handling or whether the analyzed participants represent everyone randomized. Nor does it report the detailed model specification or a complete statistical analysis plan. These limitations constrain how far the estimate can be generalized beyond the stated analysis.
In short, the posted result is a short-term, baseline-adjusted comparison with a negative point estimate but substantial uncertainty around the between-group difference. It should be described as an estimate from this trial’s recorded analysis, not as a definitive conclusion about the overall value or safety of the polypill strategy.
14. Why This Trial Matters Statistically
This trial asks a statistical question about a medication-delivery strategy, not only about the pharmacologic components. The polypill combines several medicines in a fixed-dose product, while usual care uses the individual medicines prescribed by a provider. A randomized comparison can therefore examine the combined strategy in the context of post-ACS care. The registry’s primary endpoint captures one short-term laboratory outcome relevant to the included statin.
The distinction between a within-group change and a between-group difference is central. The registry reports a negative least-squares mean change for the polypill group and a small positive estimate for usual care, but the formal comparative estimate is the net difference. Its confidence interval spans zero. This illustrates why group-specific estimates should not be used alone to make a comparative claim.
The confidence interval also makes precision visible. A point estimate is only one summary of the data; the range around it conveys that the study result remains compatible with materially different underlying contrasts. The p-value complements, but does not replace, that information. Reading the estimate, interval, and endpoint together gives a more complete statistical interpretation.
The record also highlights the importance of transparent reporting. The population is defined by completion of the 1-month visit and availability of LDL-C, while missing-data procedures and the full analysis plan are not reported. Those details affect how readers assess the scope and robustness of a result. The posted information supports a focused interpretation of the primary comparison, while leaving questions about secondary outcomes, multiplicity, and analysis populations unanswered.
15. 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 endpoint analysis is defined by completion of the 1-month visit with LDL-C, but the registry record does not report the number of randomized participants with missing measurements, why values were missing, or how missing data were handled. This limits assessment of whether the analyzed population may differ from participants without an observed outcome.
The record describes baseline-adjusted linear regression but does not report the full model specification, covariates beyond baseline, model diagnostics, or assumptions. The reported estimate and confidence interval can be interpreted as the sponsor’s model-based result, but the information available does not permit a detailed independent assessment of that model.
The trial is listed as open label. The registry record does not say whether LDL-C measurement or laboratory assessment was blinded to assignment. The record also does not give the allocation-generation or concealment details, so those design procedures cannot be evaluated from the listed information.
The primary endpoint is measured at 1 month. Longer-term results for LDL-C and clinical outcomes are not reported in the registry record. Although secondary outcomes are listed, their results are not available in this account. The registry record does not report whether multiplicity was addressed, the original sample-size justification, a detailed protocol, or a full statistical analysis plan.
Finally, the population is described as underserved, but the registry information does not detail participants’ demographic or clinical characteristics. That absence limits assessment of how the analyzed participants compare with other populations. The findings should be interpreted within the recorded trial setting and primary analysis population, rather than generalized beyond the information documented.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Polypill in Acute Coronary Syndrome — NCT05514938.
- Registry record last updated 2026-09-22; status last verified 2026-09.
- Results first posted 2026-05-14.
- 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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19. Record Summary
NCT05514938 is a completed phase 2 randomized, open-label, parallel-group study sponsored by the University of Texas Southwestern Medical Center. It compares a once-daily polypill strategy with usual care using individual medications after acute coronary syndrome or high-risk PCI in an underserved patient population.
The primary outcome is baseline-adjusted change in LDL-C at 1 month among participants who completed the visit with an LDL-C measurement. The reported between-group mean difference (net) is -4.58 mg/dL, with a 95% confidence interval from -12.68 to 3.52 mg/dL and p = 0.27. The interval includes zero, so the posted estimate remains uncertain about the size and direction of the between-group difference.
The registry lists secondary outcomes for self-reported adherence, treatment satisfaction, and quality of life at 1 month. The registry record does not report their results in the information, nor does it detail missing-data handling, the complete analysis plan, or the sample-size justification.