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 Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study (NCT01632878), a registered phase not stated study. The primary outcome is Number of Occurrences of Cardio-vascular Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01632878 |
| Phase | Phase not stated |
| Condition | Myocardial Infarction (MI) |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 1531 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Mylan Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients after an index myocardial infarction. The registry describes one cohort of post-myocardial-infarction patients and reports enrollment of 1531. It does not report further eligibility details or a more specific description of the population included in the primary outcome assessment.
Intervention
The cohort of interest consisted of patients prescribed Omacor as part of their standard secondary prevention treatment. The study was observational: treatment was recorded in clinical practice rather than assigned by the study. The registry does not report the treatment regimen, adherence, or how treatment decisions were made.
Comparator
No randomized comparator is described. The study first collected information on current treatment of post-myocardial-infarction patients through a screening log, then prospectively evaluated patients prescribed Omacor. The screening-log information is not described as a like-for-like control group, and the registry does not report a comparative analysis.
Primary question
The primary outcome is the number of occurrences of cardiovascular events during 12 months. The listed examples are recurrent nonfatal myocardial infarction, sudden death, and new congestive heart failure. The study aimed to observe clinical and patient-reported outcomes, especially but not exclusively these events. The registry does not report the observed primary outcome count or an estimate of association between Omacor use and outcomes.
In statistical terms, this is a question about describing events among a treated observational cohort, not estimating a randomized treatment contrast. Observed event counts could characterize what was recorded during follow-up, but a count alone would not establish what would have happened to the same patients under a different treatment. Patient characteristics, concurrent care, treatment selection, and data availability can all influence observational findings. The registry record does not report an adjusted comparison or enough information to assess those influences.
3. Trial Design
OPTIMISE is described as a prospective, multicenter, multinational, structured data-collection initiative. The record states that it first compiled information on current treatment of post-myocardial-infarction patients in a screening log. It then prospectively evaluated patients prescribed Omacor as part of standard secondary prevention. The study is identified as observational, and its arm description names one cohort of index post-myocardial-infarction patients.
There is no randomized allocation described, and the allocation method is not stated. The screening-log group should therefore not be treated as a randomized control group or assumed to be comparable with the Omacor cohort. The registry explicitly cautions that the arms are not a like-for-like control comparison. The design does not support interpreting any difference between separately recorded groups as a treatment effect without an appropriate design and analysis, neither of which is reported.
The planned observation period for the Omacor cohort was 12 months. No additional visits, medical tests, laboratory tests, procedures, or interventions were mandated. The record says that results from routinely performed tests, laboratory tests, procedures, or interventions would be collected if available. This approach may describe care as it occurred in practice, while making the completeness and timing of information dependent on routine care and data availability.
The record reports enrollment of 1531, a start date of 2012-07, primary completion in 2014-12, and status COMPLETED. It does not explain the relationship between the enrollment figure and the population contributing to the reported safety figures. A protocol, detailed eligibility criteria, recruitment flow, follow-up completion, and the rationale for the planned sample size are not reported in the registry record. The sponsor is Mylan Inc. The registry lists one outcome measure and no analyses.
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: 268 patients screened but not treated with Omacor on physician decision as per the protocol. Consequently 1263 entered in Omacor 1 year treatment assessment
Screening
| Stage | Post Myocardial Infarction |
|---|---|
| STARTED | 1531 |
| COMPLETED | 1263 |
| NOT COMPLETED | 268 |
Reasons for not completing this period:
| Reason | Post Myocardial Infarction |
|---|---|
| Physician Decision | 268 |
Treatment
| Stage | Post Myocardial Infarction |
|---|---|
| STARTED | 1263 |
| COMPLETED | 1105 |
| NOT COMPLETED | 158 |
Reasons for not completing this period:
| Reason | Post Myocardial Infarction |
|---|---|
| Lost to Follow-up | 41 |
| Withdrawal by Subject | 36 |
| Physician Decision | 34 |
| missing information | 4 |
| no information on study completion | 43 |
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 | Post Myocardial Infarction Omacor Group | Post Myocardial Infarction Non-Omacor Group | Total |
|---|---|---|---|---|
| Participants analysed | 1263 | 268 | 1531 | |
| Age, Continuous | years | 59.1 (SD 10.64) | 59.6 (SD 11.37) | 59.2 (SD 10.77) |
| Sex/Gender, Customized: male | participants | 948 | 203 | 1151 |
| Sex/Gender, Customized: female | participants | 311 | 61 | 372 |
| Sex/Gender, Customized: unknown | participants | 4 | 4 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Occurrences of Cardio-vascular Events, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | events |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Number of Occurrences of Cardio-vascular Events.” Its unit is events, its measure type is a number, and its timeframe is 12 months. The listed examples are recurrent nonfatal myocardial infarction, sudden death, and new congestive heart failure. The description says “such as,” so those examples are not stated to be an exhaustive definition of every event included.
A count endpoint describes how many events were recorded, rather than simply whether each participant experienced at least one event. In general, counting events can retain information about recurrence: a participant with more than one event may contribute more than a participant with a single event. The registry record does not specify exactly how events were defined, adjudicated, attributed, or counted for an individual participant. It also does not report whether the count was analyzed as a total across the cohort or by another method.
In general, a cardiovascular event count is relevant to an observational study seeking to describe clinical outcomes after myocardial infarction. Interpretation depends on the observation period, completeness of event capture, and the population included in the count. The record sets the timeframe at 12 months, but the primary outcome result, its distribution, and any uncertainty estimate are not reported in the registry record. The registry also does not state the primary outcome population in further detail.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the purpose and design of an observational cohort study, but it does not report the primary cardiovascular event count or a statistical analysis of that outcome. Consequently, no estimate of event frequency, uncertainty interval, or comparison between treatment groups can be interpreted from the recorded primary outcome information. The absence of a posted result is not evidence that no events occurred; the result is not reported in the registry record.
The study aimed to observe patients prescribed Omacor as part of standard secondary prevention. Because treatment was not randomly assigned in the described design, the cohort's outcomes would reflect both treatment and the clinical circumstances in which it was prescribed. In general, observational data can be useful for describing routine practice and generating questions, but comparisons between treated and untreated groups can be affected by differences in patient characteristics, other care, and reasons for treatment selection. Here, the registry does not present a randomized comparison or an adjusted analysis, and it cautions that the arms are not a like-for-like control comparison.
The planned primary endpoint is a count of cardiovascular events over 12 months. Counts need context: the number of people observed, their length of follow-up, and how completely events were recorded affect what the count means. The study description says that no extra visits or tests were required and that routine-care results would be collected if available. This may make data more reflective of usual care, while leaving the completeness of event ascertainment dependent on what was documented. The registry does not report the completeness of follow-up or event capture.
The safety information reports 43 participants with serious adverse events among 1263 at risk in the post-myocardial-infarction group. This is a recorded safety summary, not a randomized estimate of harm attributable to Omacor. The listed serious-event terms and percentages are descriptive, and the registry does not provide comparative safety analyses or enough detail to determine how the percentages were calculated.
Statistical precision cannot be assessed for the primary outcome because no estimate or confidence interval is reported. In general, a confidence interval describes the range of values reasonably compatible with an estimate under a statistical model; its width reflects uncertainty. No such interval, p-value, or model-based result is reported for the endpoint. The record also lists no analyses. The completed status and enrollment figure describe the study record, but do not substitute for an outcome analysis. The posted information therefore supports a description of the study's aims and design, not a conclusion about the magnitude or direction of an association between Omacor and cardiovascular events.
9. Statistical Methods Explained
The statistical method that can be identified from the record is the intended measurement: a number of cardiovascular event occurrences during 12 months. The record specifies events as the unit and identifies the measure as a number. It does not report a model, an estimator, a hypothesis test, a confidence interval, or an analysis result. The registry lists no analyses. Accordingly, interpretation should distinguish the planned outcome from any inferential result: the endpoint is described, but its observed value and statistical analysis are not reported in the registry record.
What does a count outcome represent?
In general, a count outcome records how many times an event occurs in a defined population and observation period. Unlike a binary outcome, which records whether an event occurred at least once, a count may retain information about repeated events. How that information is used depends on the study's event definition and analysis plan. The registry lists recurrent nonfatal myocardial infarction, sudden death, and new congestive heart failure as examples of cardiovascular events. It does not say whether the categories were combined into a single count, whether every event type was included, how recurrence was handled, or how events were confirmed.
Counts are often interpreted alongside the amount of time people were observed. In general, if participants have different follow-up durations, a raw total may not represent the same exposure time for each person. The study's stated observation period is 12 months, but the record does not report individual follow-up duration, losses to follow-up, or a rate analysis. It also does not state whether the primary outcome count was based on all enrolled participants, only those with complete follow-up, or another analysis population.
Why can counts require special statistical care?
General statistical guidance is that count data may be unevenly distributed: many participants can have no events while a smaller number have several. Some count models assume a particular relationship between the average count and its variability. Over-dispersion occurs when the observed variability is greater than a model's assumptions allow; if ignored, uncertainty estimates can be too small and inferential conclusions may appear more precise than warranted. This is a general consideration, not a statement about the distribution in OPTIMISE. The registry record does not report the event-count distribution, a dispersion assessment, or a count-data model.
In general, another consideration is whether the analysis treats each participant's events as independent observations. Repeated events from the same person are related, so an analysis of event counts may need to account for within-person clustering. A different approach may be appropriate if the question concerns time to a first event rather than the number of occurrences. These are general methodological distinctions. The registry record does not state whether it used a recurrent-event method, a time-to-first-event method, a count model, or another approach.
What does the planning illustration mean?
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. Those assumptions describe an illustrative planning calculation, not the design of this observational study. The described study has one cohort, no randomized comparison, and no stated allocation; the assumed two-arm equal allocation should not be mistaken for actual assignment or a study protocol.
In general, a sample-size calculation asks how much information a planned study might need under stated assumptions. The result depends on assumptions about the effect, variability or event frequency, allocation, and analysis. A planning illustration does not establish the study's actual power after data collection, and it does not replace an observed estimate or uncertainty interval. The record does not report the study's own sample-size justification, nor does it report calculated planning values in the registry information. No claim about observed power can be drawn from the illustration.
What can be inferred from missing analysis details?
The absence of a named statistical model means that model assumptions cannot be checked from the registry record. There is no reported adjustment set, handling of follow-up time, missing-data method, confidence interval, or p-value for the primary endpoint. General statistical principles can explain why these details matter, but cannot identify what was actually done. The registry does not report interim analyses or a detailed statistical analysis plan. It also does not report whether any outcome definitions or analyses changed over time.
For an observational study, adjustment can sometimes address measured differences between groups, but it cannot by itself remove bias from unmeasured differences. That general point does not imply that OPTIMISE performed an adjustment: no adjusted analysis is listed. In addition, because the record does not describe a comparable control group, a treatment-effect estimate should not be inferred from the cohort description. The appropriate reading is limited to the design and outcome definition that are recorded, with the primary result and analysis remaining unreported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no analyses. It does not report a detailed statistical analysis plan, a hierarchy of outcomes, a multiplicity adjustment, or the use of interim analyses. With no inferential results listed, there is no reported set of hypothesis tests from which to assess how multiple comparisons were handled. The absence of an adjustment description does not establish that multiplicity was or was not addressed in analyses outside the registry record.
In general, multiplicity arises when several outcomes, time points, subgroups, or hypotheses are tested. Repeated testing can increase the chance of a statistically notable result arising by chance, so a prespecified approach may be important when confirmatory claims are intended. This is general statistical context; the registry record does not indicate that such a testing strategy was used for OPTIMISE.
Missing-data handling is also not reported in the registry record. The study description says that no additional visits, tests, procedures, or interventions were mandated and that results from routine care would be collected if available. It does not describe how unavailable routine-care information, incomplete follow-up, or participants without endpoint data were handled. There is no reported imputation method, complete-case rule, sensitivity analysis, or accounting of missing outcome information.
The analysis populations are not specified. In particular, the record does not explain which participants were included in the primary outcome analysis or how the enrollment figure relates to the safety population. It does not report exclusions, follow-up completion, or participant flow through analysis. These omissions limit assessment of selection and missing-data effects. They should be read as gaps in the registry information, not as evidence that any particular method was used.
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 |
|---|---|---|---|
| Post Myocardial Infarction | 43 | 1263 | 3.4% |
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 |
|---|---|
| Post Myocardial Infarction | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | Post Myocardial Infarction |
|---|---|---|
| Angina unstable | Cardiac disorders | 9 of 1263 |
| Atrial fibrillation | Cardiac disorders | 5 of 1263 |
| Myocardial infarction | Cardiac disorders | 4 of 1263 |
| Coronary artery disease | Cardiac disorders | 2 of 1263 |
| Pneumonia | Infections and infestations | 2 of 1263 |
| Angina pectoris | Cardiac disorders | 2 of 1263 |
| Atrial flutter | Cardiac disorders | 2 of 1263 |
| Cardiac failure | Cardiac disorders | 2 of 1263 |
| Cardiac failure congestive | Cardiac disorders | 2 of 1263 |
| Sudden death | General disorders | 2 of 1263 |
Serious events with the highest arm-level rate: angina unstable (0.7%), atrial fibrillation (0.4%), myocardial infarction (0.3%), coronary artery disease (0.2%), pneumonia (0.2%).
The safety record lists a post-myocardial-infarction group with 1263 participants at risk and 43 participants affected by serious adverse events. These figures describe the posted serious-event summary. They do not establish that the events were caused by Omacor, and they do not constitute a comparison with an untreated or randomized group.
The listed serious adverse-event terms and percentages are Angina unstable, 0.7%; Atrial fibrillation, 0.4%; Myocardial infarction, 0.3%; Coronary artery disease, 0.2%; Pneumonia, 0.2%; and Angina pectoris, 0.2%. The registry does not state the denominator or calculation details for these term-specific percentages, or whether individuals could appear under more than one term. They should therefore be read as the recorded descriptive percentages, not converted into counts or treated as mutually exclusive categories.
The record lists zero participants at risk and zero affected for other adverse events, so those entries do not provide a meaningful basis for assessing non-serious adverse events. Deaths are not reported in the registry record. The registry also does not provide event timing, duration, severity criteria, exposure duration, or a comparative safety analysis. These details are important for interpreting safety summaries, but cannot be inferred from the listed figures.
12. What the Result Does, and Does Not, Mean
The study record describes a prospective observational effort to collect information about post-myocardial-infarction care, with focused follow-up of patients prescribed Omacor as part of standard secondary prevention. It identifies a cardiovascular event count over 12 months as the primary outcome and gives examples of events of interest. This information clarifies what the study set out to observe, but it does not provide the primary outcome result.
The record does not report the number of cardiovascular events observed, a rate, an estimate of uncertainty, or a statistical comparison. Therefore, the information does not quantify the event experience in the cohort or establish the direction or size of an association between Omacor and cardiovascular outcomes. It also cannot show whether any observed outcome would have differed under another treatment, because no randomized comparison is described and the registry warns that the arms are not a like-for-like control comparison.
In general, observational studies can document how care and outcomes appear in clinical practice. Their findings are shaped by who receives a treatment, what other care is given, how outcomes are recorded, and which participants contribute data. For OPTIMISE, the record says that routine-care data would be collected when available and that no extra tests or visits were mandated. It does not report how complete the outcome information was or whether differences between groups were addressed analytically.
The serious adverse-event figures are descriptive safety information. They do not on their own attribute events to a treatment, establish comparative risk, or provide a complete account of all adverse events. The absence of a reported primary outcome analysis should not be interpreted as a null result, and the completed study status should not be interpreted as proof of a particular finding. The registry record supports conclusions about the study's stated design and the information it recorded, while the central clinical outcome result and its statistical interpretation remain unreported.
13. Why This Trial Matters Statistically
OPTIMISE illustrates an important distinction between a study's clinical aim and the evidence available for statistical interpretation. The stated aim was to observe outcomes after myocardial infarction among patients prescribed Omacor within standard secondary prevention. The registry identifies a clinically relevant event-count endpoint and a 12-month timeframe. Yet a clear endpoint definition and a completed study status do not, by themselves, provide an estimate of event frequency or treatment association.
The observational design is also central to interpretation. In general, treatment choice in routine practice may be related to patient characteristics and clinical circumstances. A treated cohort can describe what was observed among its participants, but a causal contrast requires a credible basis for comparing outcomes under different treatment strategies. OPTIMISE is described as having one cohort, with no randomized allocation stated; the registry specifically cautions that the arms are not a like-for-like control comparison. That makes it especially important not to read a cohort description as evidence of a treatment effect.
The study's routine-data approach highlights a practical trade-off. In general, collecting information generated during usual care can reduce study-mandated procedures and reflect clinical practice. At the same time, outcome ascertainment and completeness may depend on what was recorded and available. The registry states that additional visits and tests were not mandated, but does not report the completeness of follow-up or the handling of missing information.
Finally, the record shows why transparent reporting of estimates and analysis methods matters. Without the primary event count, an uncertainty measure, and a stated analysis, readers cannot assess precision, model assumptions, or the influence of missing data. The study's design and endpoint are informative, but the clinical outcome result is not reported in the registry record.
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 OPTIMISE is that the registry record does not report the primary cardiovascular event count or an analysis of that outcome. Without an estimate, uncertainty interval, or stated model, the magnitude and precision of the observed endpoint cannot be assessed. The registry lists no analyses, so it does not provide inferential results for the primary outcome.
The study is observational, with one described cohort and no randomized allocation stated. The record cautions that the arms are not a like-for-like control comparison. Consequently, the design description does not support a direct randomized treatment contrast. The registry does not report an adjusted analysis or details about treatment selection, participant characteristics, or other factors that could influence outcomes.
The primary endpoint description gives examples of cardiovascular events but does not provide a detailed operational definition, event-adjudication process, or rules for recurrent events. Although the timeframe is 12 months, individual follow-up duration and completeness are not reported. Because routine-care data were to be collected when available and no extra tests or visits were mandated, the record does not establish how completely events were captured.
The analysis population and the relationship between enrollment of 1531 and the safety group of 1263 at risk are not explained. Missing-data methods, participant flow, eligibility details, and outcome-specific denominators are not reported. The safety percentages are listed without a denominator or calculation details for each term, and deaths are not reported in the registry record. These limitations concern what can be assessed from the registry information; they do not establish that particular procedures were absent from other study documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study — NCT01632878.
- Registry record last updated 2022-03-31; status last verified 2016-04.
- Results first posted 2016-05-09.
- 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
OPTIMISE (NCT01632878) is a completed prospective, multicenter, multinational observational data-collection study sponsored by Mylan Inc. It concerns patients after myocardial infarction and describes one cohort of patients prescribed Omacor as part of standard secondary prevention. Enrollment was 1531; the recorded start was 2012-07 and primary completion was 2014-12.
The primary outcome is the number of cardiovascular event occurrences during 12 months, with recurrent nonfatal myocardial infarction, sudden death, and new congestive heart failure given as examples. The registry lists one outcome measure and no analyses. It does not report the primary outcome result, its precision, or a comparative treatment analysis. The safety record reports 43 participants affected by serious adverse events among 1263 at risk, with listed term-specific percentages. Those figures are descriptive and do not establish treatment causation.