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 Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome (NCT00728988), a randomized phase 4 study. The primary outcome is Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00728988 |
| Phase | Phase 4 |
| Condition | Acute Coronary Syndrome |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 499 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Asian patients with acute coronary syndrome undergoing early percutaneous coronary intervention (PCI) were the population of interest. The study summary specifies non-ST-elevation acute coronary syndrome (NSTE-ACS) and says the study was conducted in China and the Republic of Korea. The primary analysis population was the Full Analysis Set: participants who received at least one dose of study medication and underwent PCI.
Intervention
The study compared atorvastatin pre-treatment with usual care. The summary describes a high pre-treatment dose of atorvastatin, but the registry record does not report the dose, timing, or detailed treatment schedule in the arm descriptions.
Comparator
The comparator was usual care. The record does not give further details of the usual-care regimen or describe the specific treatments participants received in either arm.
Primary question
The primary endpoint was the percentage of participants experiencing major adverse cardiac events (MACE) within 30 days after PCI. MACE was defined as death, myocardial infarction, or target-vessel revascularization. The clinical question is whether the observed frequency of this composite outcome differed between the randomized groups. The registry record does not report the primary endpoint results, so it does not establish the direction or precision of any between-group difference.
3. Trial Design
This was a Phase 4, randomized, open-label, parallel-group comparative study. The registry lists an enrollment of 499 and a completed status. The listed start and primary completion dates are 2008-09 and 2010-04. The study summary describes patients with NSTE-ACS in China and the Republic of Korea undergoing early PCI.
Participants were assigned to atorvastatin pre-treatment or usual care. Random allocation can help balance measured and unmeasured characteristics between groups on average, though it does not guarantee balance in a particular trial. The study was open-label, meaning the treatment assignment was not masked according to the registry. The record does not report further details about allocation procedures, concealment, or who knew each participant’s assignment.
The primary endpoint was a binary participant-level outcome: whether a participant experienced MACE during the specified post-PCI period. The primary analysis population was the Full Analysis Set, defined as participants who received at least one study-medication dose and underwent PCI. The endpoint description also specifies last observation carried forward (LOCF), but the record does not explain how that method was applied to this outcome.
The listed secondary outcomes include MACE at earlier post-PCI time points, elevated cardiac biomarkers, and change in C-reactive protein. The record lists seven outcome measures and 20 analyses. It does not provide detailed arm descriptions, treatment dose and schedule, a statistical analysis plan, or a sample-size justification. The registry record also does not report the primary endpoint results needed to assess the comparison.
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 | Atorvastatin | Usual Care |
|---|---|---|
| STARTED | 247 | 252 |
| Treated | 245 | 250 |
| Full Analysis Set | 163 | 172 |
| COMPLETED | 154 | 164 |
| NOT COMPLETED | 93 | 88 |
Reasons for not completing this period:
| Reason | Atorvastatin | Usual Care |
|---|---|---|
| Not Treated | 2 | 2 |
| Death | 1 | 1 |
| Adverse Event | 3 | 2 |
| Other | 85 | 77 |
| Withdrawal by Subject | 2 | 6 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF).
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 | Atorvastatin | Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 247 | 252 | 499 | |
| Age, Customized: 18 to 44 years | participants | 23 | 9 | 32 |
| Age, Customized: 45 to 64 years | participants | 134 | 156 | 290 |
| Age, Customized: >= 65 years | participants | 90 | 87 | 177 |
| Sex: Female, Male: Female | Participants | 81 | 77 | 158 |
| Sex: Female, Male: Male | Participants | 166 | 175 | 341 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI), measured over 30 days post PCI.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with MACE 30 days after PCI. The registry defines MACE as death, myocardial infarction, or target-vessel revascularization within 30 days post-PCI. It says events occurring after 33 days post-PCI were excluded. Because the endpoint combines several event types, a participant is counted as having the composite outcome if any of its specified components occurs during the defined period.
Composite endpoints are used in clinical research to represent a set of clinically important events in one outcome measure. They can capture more than one way a participant may experience an adverse outcome, but the components may differ in severity and frequency. A composite result alone does not show which component contributed most to the overall pattern. Component-specific results are therefore useful for understanding what the combined endpoint represents.
The registry specifies the Full Analysis Set as the analysis population: participants who received at least one dose of study medication and underwent PCI. It also specifies LOCF. The record does not report participant counts for the primary endpoint, an effect estimate, or a confidence interval. Consequently, the magnitude and precision of the between-group comparison cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of atorvastatin pre-treatment and usual care in patients with acute coronary syndrome undergoing early PCI. Its primary outcome is the percentage of participants who experienced MACE within 30 days after PCI. However, the record available for this analysis does not include the primary outcome results. There are no reported event counts or group percentages for the primary endpoint, nor a reported between-group effect estimate or confidence interval. The direction, size, and precision of the primary comparison are therefore not reported in the registry record.
This absence of primary outcome results is central to interpretation. The trial design and endpoint definition explain what the researchers intended to compare, but they do not indicate what the comparison found. Enrollment and completion status are not outcome evidence. Without the reported outcome data, it is not possible to evaluate whether the groups differed on the primary endpoint or how compatible the data are with different possible effects.
The endpoint combines death, myocardial infarction, and target-vessel revascularization. A result for the composite would describe the combined occurrence of these events, not necessarily the pattern for each component. The registry record does not report component-specific primary outcome results, so their individual contributions cannot be assessed. Nor does the record provide details that would allow assessment of the number or handling of missing primary endpoint observations.
The record lists secondary outcomes including MACE at 8 hours and 24 hours post-PCI, elevated creatine kinase-MB, troponin I, and myoglobin, and change in C-reactive protein. It lists seven outcome measures and 20 analyses, but the outcome values for those measures are not included in the registry record for this interpretation. They should not be treated as evidence of a particular treatment effect. A large number of outcomes or analyses can also make it important to understand how the analyses were planned and how multiplicity was addressed; those details are not reported in the registry record.
Safety information is reported separately: the serious adverse-event counts are 16 in each group, with 245 participants at risk in the atorvastatin group and 250 in usual care. The record also lists other adverse-event counts of 65 and 45, respectively. These figures describe the posted safety counts and should not be substituted for the primary MACE result. The record does not supply enough information to establish how the safety events relate to the primary endpoint, or to make a causal interpretation of the counts.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group study with no masking. These design features frame how a comparison can be interpreted, but do not by themselves establish the quality of every analysis. Randomization is intended to create groups that are comparable at baseline on average. In an individual trial, differences can still occur by chance, and the record does not give baseline characteristics or details about the randomization procedure. Open-label assignment means participants and study personnel were not masked to treatment assignment according to the registry. Knowledge of assignment can affect care, reporting, or outcome assessment, depending on the endpoint and study procedures. The record does not describe any safeguards against such influences.
What does a binary endpoint measure?
The primary outcome is a binary participant-level measure: each participant either experienced a qualifying MACE during the defined period or did not. The registry expresses the outcome as a percentage of participants. For this kind of endpoint, a group result is based on the number of participants meeting the event definition relative to the relevant analysis population. No primary event counts or percentages are reported in the registry record, so no primary group comparison can be reconstructed from the available information.
A treatment comparison for a binary outcome can be expressed in different ways, such as a difference in event proportions or a ratio of proportions. These measures answer related but distinct questions. A confidence interval communicates the range of effect values that are reasonably compatible with the data under the analysis assumptions; it also reflects statistical uncertainty. A narrow interval indicates greater precision than a wide one. Neither an estimate nor its interval is reported for the primary endpoint in the registry record, so its magnitude and precision cannot be described.
How should the composite endpoint be understood?
MACE combines death, myocardial infarction, and target-vessel revascularization. Combining components can provide a single measure of whether any specified event occurred, but it can conceal differences among components. For example, a composite result does not indicate whether one component was more common than another, or whether the components followed similar patterns across groups. Component-level results are needed to make those distinctions. They are not reported for the primary endpoint in the registry record.
The registry defines the main time period as 30 days post-PCI and states that MACE occurring after 33 days post-PCI was excluded. These are the time-window details recorded for the endpoint. The record does not explain the reason for the 33-day exclusion threshold or describe how events were ascertained and adjudicated.
What role does the analysis population play?
The Full Analysis Set is defined as participants who received at least one dose of study medication and received PCI. The primary endpoint description also names LOCF. In general, an analysis population defines which participants contribute to an analysis, and the choice can affect how the results relate to the randomized comparison. The registry record does not report how many participants were included in this population by group, how many were excluded, or whether all randomized participants were analyzed as assigned.
LOCF is a method for handling missing follow-up measurements by carrying a participant’s last observed value forward. As a general statistical matter, this approach relies on assumptions about how the unobserved value relates to the last measurement. The registry record does not say how LOCF was used for the binary MACE outcome, how many observations were missing, or whether alternative missing-data analyses were performed. Those details are necessary to assess the influence of missing data.
What can be inferred from planning illustrations?
Planning calculations answer a design question: how many participants might be needed under specified assumptions to detect an effect of a chosen size with a chosen statistical procedure. The stated planning approach uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect set as a fraction of the observed effect. These are planning illustrations based on an observed effect, not evidence that the trial had a particular probability of detecting an effect after the fact. Sample-size calculations are not observed power, and they do not replace the trial’s outcome estimate or its uncertainty.
The registry record does not report the trial’s own sample-size justification or detailed statistical plan. It also does not report an interim-analysis plan, the handling of multiplicity, or a prespecified hierarchy for outcomes. These omissions limit assessment of how the posted analyses relate to the original design decisions. The primary endpoint results themselves are not reported in the registry record, which prevents a statistical assessment of the principal treatment comparison.
10. Multiplicity, Missing Data and Analysis Populations
The record lists seven outcome measures and 20 analyses, including the primary MACE endpoint, earlier MACE time points, biomarker outcomes, and change in C-reactive protein. When many outcomes or analyses are examined, the chance of at least one apparently notable result can increase. A prespecified testing sequence or multiplicity adjustment can address aspects of this concern. The registry record does not report whether such procedures were planned or used, and it does not identify a hierarchy among the listed outcomes.
The primary endpoint description names the Full Analysis Set and LOCF. The set includes participants who received at least one dose of study medication and underwent PCI. The record does not report the number analyzed by group, the number excluded from the randomized population, or reasons for exclusion. It does not provide missing-data counts or explain how LOCF was applied to the binary endpoint. Whether other missing-data approaches were considered is not reported in the registry record.
The registry record does not report a statistical analysis plan, sample-size justification, or interim-analysis details. Without those details, it is not possible to determine from the record whether the analyses were fully prespecified, how missing observations were handled in practice, or how the reported set of analyses was selected. These limitations are especially important because the primary endpoint results are not reported in the record available for this analysis.
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 |
|---|---|---|---|
| Atorvastatin | 16 | 245 | 6.5% |
| Usual Care | 16 | 250 | 6.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Atorvastatin | 65 of 245 |
| Usual Care | 45 of 250 |
Most frequent serious adverse event terms
| Event term | Organ system | Atorvastatin | Usual Care |
|---|---|---|---|
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | 4 of 245 | 7 of 250 |
| Myocardial infarction | Cardiac disorders | 3 of 245 | 4 of 250 |
| Chest pain | General disorders | 1 of 245 | 1 of 250 |
| Acute myocardial infarction | Cardiac disorders | 1 of 245 | 0 of 250 |
| Angina unstable | Cardiac disorders | 0 of 245 | 1 of 250 |
| Atrial fibrillation | Cardiac disorders | 1 of 245 | 0 of 250 |
| Palpitations | Cardiac disorders | 1 of 245 | 0 of 250 |
| Visual impairment | Eye disorders | 1 of 245 | 0 of 250 |
| Gastritis | Gastrointestinal disorders | 1 of 245 | 0 of 250 |
| Gastritis erosive | Gastrointestinal disorders | 1 of 245 | 0 of 250 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Atorvastatin | Usual Care |
|---|---|---|---|
| Headache | Nervous system disorders | 29 of 245 | 18 of 250 |
| Myocardial infarction | Cardiac disorders | 15 of 245 | 12 of 250 |
| Chest pain | General disorders | 13 of 245 | 11 of 250 |
| Back pain | Musculoskeletal and connective tissue disorders | 14 of 245 | 7 of 250 |
Serious events with the highest arm-level rate: post procedural myocardial infarction (2.8%), myocardial infarction (1.6%), acute myocardial infarction (0.4%), atrial fibrillation (0.4%), palpitations (0.4%).
The registry reports serious adverse-event counts of 16 for the atorvastatin group and 16 for the usual-care group. The corresponding numbers at risk are 245 and 250. It also lists other adverse-event counts of 65 and 45, respectively. These are posted safety figures; they are distinct from the primary MACE endpoint and do not supply its outcome results.
The serious adverse-event terms listed most often include post procedural myocardial infarction (2.8%), myocardial infarction (1.6%), acute myocardial infarction (0.4%), atrial fibrillation (0.4%), palpitations (0.4%), and visual impairment (0.4%). These percentages are quoted as recorded. The registry record does not provide further detail about the event-level denominators or how the listed terms overlap with each other or with the primary endpoint.
Adverse-event counts alone do not show whether events were caused by study treatment. Interpretation also depends on definitions, observation time, participant characteristics, and the way events were collected. The record does not report a deaths figure. These safety data should therefore be read as descriptive registry counts, not as a standalone estimate of comparative treatment risk.
12. What the Result Does, and Does Not, Mean
The record identifies a clinical question and a randomized design: atorvastatin pre-treatment was compared with usual care in Asian patients with acute coronary syndrome undergoing early PCI. It defines a primary composite outcome of death, myocardial infarction, or target-vessel revascularization within 30 days post-PCI. These details establish what the trial set out to compare, but they do not answer the comparison on their own.
The primary outcome results are not reported in the registry record available for this analysis. There is no reported primary event count, percentage, between-group estimate, or confidence interval. As a result, the data do not show whether the groups had different MACE frequencies, how large any difference might have been, or how precisely an effect was estimated. No conclusion about a treatment effect should be drawn from the design description or enrollment alone.
The composite endpoint also has limits as a summary. It combines events that can differ in nature, and an overall composite result would not by itself reveal which component drove the result. The record does not report component-level primary results. Likewise, the listed secondary outcome names indicate additional questions of interest, but their results are not reported in the information available for this interpretation.
The reported serious and other adverse-event counts provide some descriptive safety information, but they do not replace the primary endpoint analysis and do not establish causation. The record does not report the deaths figure or give details about the handling of missing outcome data and multiplicity. Overall, the registry record supports a description of the study’s design, population definition, endpoints, and some safety counts; it does not support a complete statistical interpretation of the primary efficacy comparison.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why design details and outcome evidence must be kept separate. Randomization defines the intended basis for comparing groups, while the open-label design identifies a feature that may matter for outcome measurement and care. Neither fact tells the reader what the primary endpoint result was. The registry record specifies the question but does not report the primary comparison needed to answer it.
The endpoint also illustrates the interpretive trade-off of composite outcomes. Combining death, myocardial infarction, and target-vessel revascularization creates one binary measure, but a result for that measure would not describe the contribution of each component. Component-specific reporting is important when the components have different clinical meanings or event patterns. Those primary component results are not reported in the registry record.
The analysis population and missing-data description matter as well. The Full Analysis Set is restricted to participants who received at least one dose and underwent PCI, and LOCF is named. Without group-specific analysis counts, exclusion reasons, or an explanation of LOCF’s implementation, readers cannot evaluate how these choices affected the analysis. The record also lists multiple outcomes and analyses without reporting a multiplicity plan, leaving uncertainty about how the analysis family was handled.
Finally, the safety counts should not be confused with the primary efficacy outcome or treated as causal evidence. Taken together, the registry record illustrates that a completed randomized trial can have clearly stated design and endpoint definitions while still lacking the results and methods detail needed for a full statistical assessment.
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 primary MACE results are not reported. The record defines the endpoint and analysis population but gives no event counts, group percentages, effect estimate, or confidence interval. The primary comparison therefore cannot be evaluated for direction, magnitude, or precision. Primary component results are also not reported.
The treatment descriptions are sparse. The record names atorvastatin in both intervention entries and identifies the groups as atorvastatin and usual care, but the arm descriptions are blank. Although the study summary refers to a high pre-treatment dose, the registry record does not report the dose, timing, or detailed treatment regimen. It also does not describe usual care sufficiently to assess the contrast between groups.
Additional methodological details are not reported in the registry record: the randomization procedures, allocation concealment, statistical analysis plan, trial-specific sample-size justification, interim-analysis plan, and any multiplicity strategy. The primary analysis population is defined, but the number analyzed by group, exclusions, missing-data counts, and implementation of LOCF are not reported. These omissions limit assessment of potential bias and the robustness of any analysis.
The record lists serious and other adverse-event counts, but gives no deaths figure. The event-term percentages are recorded without further denominator or overlap details in the information available for this interpretation. The total enrollment does not by itself reveal how many participants were randomized, included in the primary analysis, or followed for the full outcome period.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome — NCT00728988.
- Registry record last updated 2021-02-21; status last verified 2021-02.
- Results first posted 2011-09-27.
- 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
NCT00728988 is a completed Phase 4 randomized, open-label, parallel-group study comparing atorvastatin pre-treatment with usual care in Asian patients with acute coronary syndrome undergoing early PCI. The registry lists enrollment of 499 and dates of 2008-09 for study start and 2010-04 for primary completion. The study summary specifies NSTE-ACS in China and the Republic of Korea.
The primary endpoint was the percentage of participants with MACE within 30 days post-PCI, defined as death, myocardial infarction, or target-vessel revascularization. The primary population was the Full Analysis Set, with LOCF specified. Primary outcome results, detailed treatment regimens, and key analysis-plan information are not reported in the registry record. Safety counts include 16 serious adverse events in each group; these counts do not provide the missing primary endpoint comparison.