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 Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction (NCT01176968), a randomized phase 4 study. The primary outcome is First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01176968 |
| Phase | Phase 4 |
| Condition | Myocardial Infarction |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1012 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with acute myocardial infarction and without heart failure, as described in the registry summary. The primary efficacy population was the Full Analysis Set using the intent-to-treat principle, regardless of study-drug compliance or protocol adherence. The record says clinical-event analyses included all available study endpoints.
Intervention
Eplerenone with standard of care, with administration described in the summary as beginning within 24 hours of symptom onset. The eplerenone dose and treatment duration are not reported in the registry record.
Comparator
Placebo with standard of care. The placebo is described as matching eplerenone 25mg film-coated tablets. Further details about standard of care are not reported in the registry record.
Primary question
Did assignment to eplerenone, compared with placebo, affect time to the first occurrence of the composite cardiovascular and cardiac outcome during 0-24 months? The composite included cardiovascular mortality, specified heart-failure hospitalization or extended initial stay, sustained ventricular tachycardia or fibrillation, low ejection fraction, or natriuretic-peptide values above age-adjusted cutoffs.
This is a question about a composite endpoint, not a single clinical event. Its components range from mortality and hospitalization to rhythm findings and measurements of cardiac function or biomarkers. A difference in the composite can reflect one component, several components, or different patterns across components. The available primary summary does not identify how much each component contributed to the between-arm result.
The registry record describes a double-blind, randomized, placebo-controlled study and reports a Cox model comparison for the primary outcome. Random allocation and masking are design features intended to support a fair comparison; they do not remove the need to examine endpoint definitions, follow-up, analysis choices, and missing-data handling. The record does not report enough detail to assess all of those features.
3. Trial Design
This was a phase 4, randomized, quadruple-masked, parallel-group trial of eplerenone plus standard of care versus placebo plus standard of care. The registry reports enrollment of 1012 and a completed status. The start is recorded as 2010-09 and primary completion as 2012-10. The record identifies myocardial infarction as the condition under study.
The study is described as double-blind in its official title and quadruple-masked in its design fields. Which specific groups of people were masked is not reported in the registry record. The placebo is described as matching eplerenone 25mg film-coated tablets. The eplerenone dose, treatment duration, detailed eligibility criteria, and the content of standard care are not reported in the registry record.
The brief summary describes administration within 24 hours of symptom onset in patients without heart failure. This supplies the broad clinical context, but does not by itself specify the complete inclusion and exclusion criteria or how symptom onset and treatment timing were operationalized. Those details are not reported in the registry record.
The primary outcome timeframe is 0-24 months. The registry identifies 14 outcome measures and 31 analyses. Those counts indicate that the record covers more than the main comparison, but do not establish how outcomes were prioritized, how many analyses were planned in advance, or which analyses were exploratory. Those planning details are not reported in the registry record.
For the primary clinical-event analysis, the stated population is the Full Analysis Set under the intent-to-treat principle, regardless of compliance with study drug or protocol. The record also says that all available study endpoints were used for clinical-event efficacy analyses. Further information about follow-up completeness, participant flow, or the handling of unavailable endpoint data is 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: A total of 1012 subjects were enrolled for participation in this study. A total of 505 subjects were randomized to treatment with eplerenone and 505 subjects were randomized to the placebo group; a total of 422 and 424 subjects in the eplerenone and placebo groups, respectively, completed the study.
Overall Study
| Stage | Eplerenone Plus Standard of Care | Placebo Plus Standard of Care |
|---|---|---|
| STARTED | 506 | 506 |
| Treated | 505 | 505 |
| COMPLETED | 422 | 424 |
| NOT COMPLETED | 84 | 82 |
Reasons for not completing this period:
| Reason | Eplerenone Plus Standard of Care | Placebo Plus Standard of Care |
|---|---|---|
| Adverse Event | 10 | 11 |
| Death | 2 | 3 |
| Lack of Efficacy | 0 | 1 |
| Lost to Follow-up | 16 | 14 |
| Withdrawal by Subject | 48 | 48 |
| Protocol Violation | 2 | 1 |
| Did Not Meet Entrance Criteria | 1 | 0 |
| Study terminated by sponsor | 0 | 1 |
| Reason not defined | 5 | 3 |
Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.
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 | Eplerenone Plus Standard of Care | Placebo Plus Standard of Care | Total |
|---|---|---|---|---|
| Participants analysed | 506 | 506 | 1012 | |
| Age, Continuous | Years | 58.5 (SD 10.8) | 57.8 (SD 11.0) | 58.2 (SD 10.9) |
| Sex: Female, Male: Female | Participants | 86 | 103 | 189 |
| Sex: Female, Male: Male | Participants | 420 | 403 | 823 |
6. Primary Endpoint
The registry lists the primary outcome as First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off, measured over 0-24 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a time-to-first-event composite assessed over 0-24 months. It includes cardiovascular mortality; rehospitalization or an extended initial hospital stay due to heart failure; sustained ventricular tachycardia or ventricular fibrillation; ejection fraction of ≤40% after 1 month; or BNP or NT-proBNP above age-adjusted cutoffs after 1 month. Cardiovascular mortality includes deaths adjudicated as due to sudden cardiac death, myocardial infarction, worsening heart failure, cardiac arrhythmia, or another cause.
For heart-failure hospitalization, the definition includes an extended stay or frequent emergency-room, observation-unit, or inpatient care, with heart failure as a primary or secondary diagnosis supported by discharge or clinical documentation and determined by the endpoint adjudication committee. The registry's endpoint description therefore combines outcomes that differ in severity and in how they are measured.
A composite can capture a broader range of clinically relevant events than any one component alone and can be analyzed as time until the first qualifying event. It also requires careful interpretation: the combined result does not show whether every component moved in the same direction, and a common or less severe component can influence the overall result. Component-specific estimates are needed to understand that pattern; the primary summary does not provide them.
The primary arm values are reported as numbers of events, while the inferential comparison is a Cox proportional-hazards estimate. Those are different summaries: the arm counts do not by themselves describe when events occurred, whereas the Cox analysis uses time-to-event information under its model.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports 92 primary events in the eplerenone-plus-standard-of-care arm and 149 in the placebo-plus-standard-of-care arm; each arm is listed with 506 participants. These are reported counts, not a complete description of the time-to-event comparison. The registry's Cox proportional-hazards analysis gives a hazard ratio of 0.581, with a 95% confidence interval from 0.446 to 0.756 and p < 0.001.
As a general statistical interpretation, a hazard ratio compares the modeled instantaneous event hazards between groups over follow-up, among participants who have not yet had the event. A value below 1 places the estimate in the direction of a lower modeled hazard for eplerenone than placebo. The reported confidence interval lies below 1, and the reported p-value indicates strong evidence against the model's no-difference reference. Neither statistic is a direct estimate of the probability that an individual participant will experience an event.
The estimate concerns the composite endpoint, not each component separately. It does not establish from the reported primary summary whether cardiovascular mortality, heart-failure events, rhythm events, ejection-fraction findings, or biomarker findings individually account for the observed comparison. Nor does the result describe effects beyond the specified 0-24 months. Component-specific results and further follow-up details are not reported in the registry record.
The analysis population is stated to follow the intent-to-treat principle, regardless of treatment compliance or protocol adherence. This preserves the randomized group comparison as defined in the record, but the record does not provide detailed information about adherence, crossover, or unavailable endpoint data. The extent to which missing data or other implementation issues could affect the estimate therefore cannot be assessed from the registry record alone.
The result is a model-based comparison within a randomized trial, not a standalone measure of clinical importance. The confidence interval communicates uncertainty about the estimated hazard ratio under the analysis, but it does not capture every source of uncertainty, such as endpoint selection, missing data, or the choice to combine different events. Interpretation should therefore consider the composite's construction and the unreported details of the analysis plan alongside the reported estimate.
9. Statistical Methods Explained
The primary comparison is reported using Cox proportional-hazards regression. This method analyzes time until a defined event and incorporates the timing of events and follow-up, rather than comparing only the number of participants with events. In this trial, the event is the first occurrence of the specified composite endpoint. The reported model estimate is a hazard ratio, with eplerenone compared with placebo.
What the hazard ratio describes
As a general explanation, a hazard is the rate at which an event occurs at a particular time among people who have not yet experienced it. A hazard ratio expresses the relative hazards under the fitted model. It is not the same as a risk ratio, an odds ratio, or a difference in event probabilities. It also does not indicate how much time an individual participant gains or loses before an event.
The proportional-hazards model assumes that the relative hazard between groups is constant over time, unless the model is extended to allow otherwise. Whether this assumption was assessed, and whether the model included covariates or stratification, are not reported in the registry record. The estimate should thus be read as the registry's stated Cox comparison, not as evidence that every modeling assumption was checked or satisfied.
Confidence intervals and p-values
A confidence interval gives a range of values compatible with the observed data and the model at the stated confidence level. It conveys precision as well as direction: a narrower interval indicates greater precision than a wider interval, while an interval spanning the no-difference reference would leave more uncertainty about direction. The reported primary interval is a 95% confidence interval. A p-value summarizes how unusual the data would be under a specified null model; it is not the probability that the null hypothesis is true, nor a measure of clinical importance. The primary p-value is reported as p < 0.001.
The primary arm counts are useful descriptive information, but the Cox estimate is not calculated from those counts alone. Timing of events and censoring contribute to time-to-event analysis. The registry does not provide participant-level data or the detailed risk sets, so an independent reconstruction of the Cox estimate is not available from the posted summary.
Why a composite needs component context
Combining outcomes can increase the number of events available for an overall comparison and cover a range of relevant outcomes. The tradeoff is interpretability: a composite can be driven more by some components than others, and components can differ in importance and frequency. The primary summary reports the composite estimate but not the component-specific estimates needed to judge their separate patterns. The definition also includes several distinct kinds of evidence, including adjudicated mortality, hospitalization, rhythm events, ejection fraction, and biomarker thresholds.
Secondary continuous outcome and recalculation
The posted QRS-duration summary is a comparison of group means at 6 months, with standard deviations. A mean difference describes the contrast between the two reported group averages. Its confidence interval expresses uncertainty in that contrast under the stated calculation. The simple recalculation is unadjusted, using posted summary statistics; the registry's own analysis is an ANCOVA of final values. The adjustment details are not reported in the registry record, so the two methods need not yield identical estimates.
For continuous outcomes, variation within groups matters because it affects the precision of a mean comparison. As a general explanation, greater variability relative to a mean difference makes it harder to distinguish a group contrast from random variation. The reported standard deviations characterize spread in the QRS measurements, but do not reveal the full distribution or whether the assumptions of a particular model fit well.
Planning illustrations are not trial power
The sample-size illustrations use the observed effect as a planning reference and consider detecting stated fractions of that effect. They assume a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are planning illustrations for a hypothetical design, not observed power and not evidence about the trial's original design. The registry's sample-size justification and original power assumptions are not reported in the registry record.
As a general explanation, planning calculations depend on the effect selected, outcome variability or event process, allocation, significance level, and desired power. A calculation based on an observed effect can be sensitive to random variation in that estimate. The illustrations should therefore be read as conditional planning scenarios, not as a definitive estimate of the number needed for a future study or a retrospective judgment about whether this trial was adequately designed.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Regression, Cox | Cox Proportional Hazard 0.581 | 0.446 to 0.756 | < 0.001 |
The primary comparison reported by the registry is the sponsor's Cox proportional-hazards analysis: hazard ratio 0.581, 95% confidence interval 0.446 to 0.756, and p < 0.001. There is no simple recalculated primary comparison in the posted summary. The reported primary arm counts alone are not sufficient to reconstruct a Cox model, which uses time-to-event information.
For the QRS-duration secondary outcome, the simple recalculation from posted summary statistics is unadjusted. It gives a mean difference of 1.31 milliseconds for placebo relative to eplerenone, with a 95% confidence interval from -1.008 to 3.628 and p = 0.268. The registry's analysis is an ANCOVA of final values, reporting a mean difference of -1.45, a 95% confidence interval from -3.55 to 0.65, and p = 0.174. The adjustment details are not reported in the registry record.
These estimates come from different analytical approaches and are not interchangeable: one is an unadjusted calculation from summary statistics, while the registry reports an ANCOVA result. The record does not flag a discrepancy. Neither estimate's p-value establishes the size or clinical importance of a difference; the confidence intervals and analysis choices are relevant to interpretation. For the primary endpoint, the registry's own analysis is the available inferential result.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and 31 analyses, but the analysis plan's approach to multiplicity is not reported in the registry record. It is therefore unclear whether outcomes were ranked in a formal hierarchy, whether selected analyses were designated confirmatory, or whether any adjustment was used to account for multiple testing. The number of listed analyses alone does not show how many were planned, nor whether all were treated as equally important.
As a general statistical explanation, evaluating multiple outcomes or analyses increases the chance that at least one result will appear statistically notable by chance. Multiplicity procedures can address this issue, but they may change the threshold for interpreting individual tests or the uncertainty attached to estimates. Without the prespecified plan, the reported secondary p-values cannot be placed in a clear confirmatory framework. The primary result is reported separately, but the registry record does not describe how the primary endpoint was protected from other analysis choices.
The primary population is described as the Full Analysis Set under the intent-to-treat principle, regardless of compliance with study drug and protocol. The record says that all available study endpoints were used for clinical-event analyses. It does not specify how unavailable endpoint information was handled, how censoring was defined, whether imputation was used, or how participants with incomplete follow-up were treated. These details are not reported in the registry record.
Missingness matters because an analysis based on available outcomes may be affected if the likelihood of outcome availability is related to treatment assignment or outcome status. As a general principle, the direction and size of such effects depend on why information is missing and on the analytical approach. The record does not provide enough detail to evaluate those possibilities. Interim analyses, stopping rules, and sample-size justification are also not reported in the registry record; no assumptions about them can be made from the completed status alone.
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 |
|---|---|---|---|
| Eplerenone Plus Standard of Care | 100 | 505 | 19.8% |
| Placebo Plus Standard of Care | 101 | 505 | 20.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Eplerenone Plus Standard of Care | 151 of 506 |
| Placebo Plus Standard of Care | 153 of 506 |
Most frequent serious adverse event terms
| Event term | Organ system | Eplerenone Plus Standard of Care | Placebo Plus Standard of Care |
|---|---|---|---|
| Angina pectoris | Cardiac disorders | 12 of 505 | 10 of 505 |
| Angina unstable | Cardiac disorders | 4 of 505 | 9 of 505 |
| Chest pain | General disorders | 4 of 505 | 9 of 505 |
| Cardiac failure | Cardiac disorders | 3 of 505 | 9 of 505 |
| Acute myocardial infarction | Cardiac disorders | 5 of 505 | 4 of 505 |
| Myocardial infarction | Cardiac disorders | 5 of 505 | 2 of 505 |
| Syncope | Nervous system disorders | 3 of 505 | 4 of 505 |
| Cardiac failure congestive | Cardiac disorders | 2 of 505 | 4 of 505 |
| Cerebrovascular accident | Nervous system disorders | 4 of 505 | 2 of 505 |
| Pericarditis | Cardiac disorders | 3 of 505 | 2 of 505 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Eplerenone Plus Standard of Care | Placebo Plus Standard of Care |
|---|---|---|---|
| Chest pain | General disorders | 23 of 506 | 24 of 506 |
| Dizziness | Nervous system disorders | 21 of 506 | 19 of 506 |
| Hypotension | Vascular disorders | 21 of 506 | 19 of 506 |
| Angina pectoris | Cardiac disorders | 16 of 506 | 22 of 506 |
| Diarrhoea | Gastrointestinal disorders | 22 of 506 | 14 of 506 |
| Cough | Respiratory, thoracic and mediastinal disorders | 16 of 506 | 17 of 506 |
| Fatigue | General disorders | 10 of 506 | 20 of 506 |
| Hypertension | Vascular disorders | 12 of 506 | 18 of 506 |
| Non-cardiac chest pain | General disorders | 16 of 506 | 13 of 506 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 12 of 506 | 17 of 506 |
Serious events with the highest arm-level rate: angina pectoris (2.4%), angina unstable (1.8%), cardiac failure (1.8%), chest pain (1.8%), acute myocardial infarction (1.0%).
The registry reports serious adverse events for each arm among 505 participants at risk: 100 affected in the eplerenone-plus-standard-of-care arm and 101 in the placebo-plus-standard-of-care arm. Other adverse events are reported among 506 participants at risk in each arm: 151 affected in the eplerenone arm and 153 in the placebo arm. These are posted counts with their stated denominators; they are not adjusted comparisons.
The record lists angina pectoris at 2.4% as the most frequent serious-event term, followed by angina unstable, cardiac failure, and chest pain at 1.8% each. Acute myocardial infarction and myocardial infarction are each listed at 1.0%. These terms describe selected reported events and do not summarize every possible safety outcome.
The registry does not report death counts in the adverse-event summary, and the criteria for collection, attribution, exposure duration, and statistical comparison are not reported in the registry record. Differences in event counts should not be read as proof of a safety difference or equivalence. Interpretation depends on event definitions, follow-up, completeness of reporting, and the clinical context; the posted figures alone do not resolve those issues.
13. What the Result Does, and Does Not, Mean
The primary result is a time-to-first-event comparison for a composite outcome during 0-24 months. The reported Cox estimate and its confidence interval place the comparison in the direction of a lower modeled hazard for eplerenone than placebo. The registry also reports fewer primary events in the eplerenone arm than in the placebo arm. These findings describe the posted trial results; they do not establish that every component of the composite differed in the same way.
A composite result is not a result for each included event. Without component-specific estimates, the relative contribution of mortality, heart-failure care, rhythm events, ejection fraction, and biomarker thresholds is unknown. The result also applies to the endpoint and timeframe defined in this record; it does not establish an effect beyond that follow-up or on outcomes not measured in the record.
Statistical evidence and clinical importance are related but distinct. A p-value addresses compatibility with a specified null model, while the estimate and confidence interval describe the size and precision of the modeled comparison. Clinical interpretation also depends on the importance of the endpoint components, the treatment burden, safety, and the completeness of follow-up. The registry summary does not provide enough information to assess all of those considerations.
The trial's randomized design supports comparison between assigned groups, and the stated intent-to-treat population retains participants according to assignment regardless of compliance. However, the record does not report detailed methods for missing data, adherence, or the proportional-hazards assumption. Those limitations constrain how fully the reported estimate can be evaluated. The findings should be read as the registry's reported statistical comparison, not as individualized medical guidance or a complete account of all evidence.
14. Why This Trial Matters Statistically
This trial illustrates how the choice of endpoint shapes the meaning of a clinical-trial result. The primary composite combines fatal events, heart-failure care, rhythm events, cardiac-function measurements, and biomarker thresholds. That construction can produce a useful broad comparison, but it also means the overall estimate cannot be interpreted as a uniform effect across every component.
It also demonstrates why time-to-event methods matter. The reported Cox estimate uses event timing and follow-up information, whereas the arm counts provide only a descriptive total. Treating the counts as if they alone represented the time-to-event effect would omit information relevant to the model. The hazard ratio, confidence interval, and p-value each answer different questions about the comparison and should be read together.
The record further shows the distinction between a trial's own analysis and a simple recalculation from summary data. The primary estimate is a Cox analysis and cannot be reconstructed from arm counts alone. For the QRS outcome, the posted ANCOVA and unadjusted recalculation are based on different analytical approaches. A numerical difference between such estimates is not automatically an error; the adjustment details and analysis plan are needed to understand why they differ.
Finally, a large set of outcomes and analyses makes prespecification and multiplicity important. The record lists many outcomes and analyses but does not report the relevant hierarchy or correction plan. That absence limits the certainty with which secondary findings can be classified as confirmatory. Together, these issues make the trial useful for statistical interpretation: a headline estimate must be understood in light of its endpoint, model, analysis population, and the information the registry does not report.
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 registry record leaves important details about the trial protocol and analysis methods unspecified. It does not report complete eligibility criteria, eplerenone dose or duration, the detailed content of standard care, the identities of the masked groups, or participant flow. The summary describes early treatment in patients without heart failure, but does not provide the operational criteria needed to assess how closely the analyzed population matches that description.
The primary result is for a heterogeneous composite, while component-specific estimates are not reported in the registry record. The model's covariate specification, checks of the proportional-hazards assumption, censoring rules, and handling of incomplete endpoint data are also not reported. These omissions limit assessment of the estimate's robustness and of how the reported event counts relate to follow-up.
The record lists many outcomes and analyses without reporting an endpoint hierarchy or multiplicity strategy. Detailed numerical results for most secondary endpoints are not reported in the registry record, so the consistency and specificity of secondary findings cannot be evaluated. The sample-size justification and original power assumptions are not reported; planning illustrations based on observed effects cannot fill that gap.
Safety summaries provide counts and selected serious-event terms, but details about event collection, attribution, exposure, and comparative testing are not reported in the registry record. The adverse-event summary also does not report death counts. These limitations do not negate the reported primary analysis, but they narrow the conclusions that can be drawn from the registry record alone.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction — NCT01176968.
- Registry record last updated 2020-12-22; status last verified 2020-12.
- Results first posted 2016-08-15.
- 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
The registry describes a completed phase 4 randomized, quadruple-masked, parallel-group comparison of eplerenone plus standard of care with placebo plus standard of care in patients after myocardial infarction. Enrollment is recorded as 1012. The brief summary describes treatment within 24 hours of symptom onset in patients without heart failure.
The primary outcome was time to the first event in a cardiovascular and cardiac composite over 0-24 months. The registry reports a Cox hazard ratio of 0.581, a 95% confidence interval of 0.446 to 0.756, and p < 0.001. The efficacy population is described as the Full Analysis Set under the intent-to-treat principle.
The record lists 14 outcome measures and 31 analyses. It does not report several details needed to assess the full analysis plan, including multiplicity procedures and missing-data handling. The primary estimate should therefore be interpreted alongside the composite's components and the limitations of the registry information.