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 Effects of Atorvastatin on Myonecrosis (NCT00344019), a randomized phase 4 study. The primary outcome is Peri-procedural Myonecrosis.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00344019 |
| Phase | Phase 4 |
| Condition | Coronary Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 97 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Beth Israel Deaconess Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients presenting with unstable angina and acute coronary syndromes who were being considered for percutaneous coronary intervention were the intended population. Eligibility required negative cardiac biomarkers measured on two separate occasions a few hours apart. The record also describes exclusions for people already taking high-dose statin therapy, anyone who had taken a statin within 24 hours before the procedure, and people with statin contraindications. The screening description says that patients continued to randomization if they met the inclusion and exclusion criteria, including stent placement. The registry lists 97 participants enrolled overall, but does not report how many were randomized or how many entered each treatment group.
Intervention
The active intervention was a single 80 mg dose of atorvastatin before angiography or PCI for acute coronary syndromes. The arm description places dosing on average 2-4 hours before the procedure. The study summary describes administration on average 4 hours before PCI, with at least 2 hours between dose and procedure. These descriptions indicate the intended timing, not confirmation of the timing received by individual participants.
Comparator
The comparator was an oral placebo tablet given before angiography or PCI. The placebo arm description gives the same average 2-4 hour timing. The study was described as randomized, placebo-controlled, quadruple-masked, and parallel-group. The registry record does not report treatment-group sizes or the number of participants who actually received either intervention.
Primary question
The primary question was whether troponin T measured 18-24 hours after PCI differed following pre-procedure atorvastatin or placebo. Troponin T was intended to quantify peri-procedural myonecrosis, meaning heart-muscle injury associated with the procedure. The record describes a planned target involving troponin T elevation and a relative reduction, but the trial closed because recruitment was slow and the data were not analyzed. It therefore reports no estimate of the treatment-group difference.
3. Trial Design
The NO-MI study, formally titled Effects of Single-Dose Atorvastatin on Peri-Procedural Myonecrosis During Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes, was a Phase 4, randomized, parallel-group trial. It was described as placebo-controlled and quadruple-masked. The sponsor was Beth Israel Deaconess Medical Center. The registry lists a start date of 2006-05, primary completion in 2008-10, and a terminated status. Enrollment was 97. The record attributes closure to slow recruitment and states that the data were not analyzed because the retention period had passed and the investigator had left the institution.
The intended comparison was a single 80 mg dose of atorvastatin against an oral placebo before PCI. The dose was planned a few hours before the procedure; the record gives slightly different descriptions of the average timing. The study summary describes patients with unstable angina and negative cardiac biomarkers on two occasions. It also describes exclusions involving existing high-dose statin treatment, recent statin use, and statin contraindications. Treatment-group counts, randomized counts, adherence, and the flow of participants from screening through follow-up are not reported in the registry record.
The study summary says the plan was to enroll 150 patients, with 75 per group, and describes the target as detecting a 30% difference in troponin level. The primary outcome description separately refers to an assumed 40% event rate for troponin T elevation and a predicted 30% relative reduction. These statements describe the intended design, not an outcome observed in the trial. The record does not report the original statistical analysis plan or sample-size justification beyond these statements. It also lists secondary interests in creatine kinase, CK-MB, C-reactive protein, and myocardial perfusion. No analysis results for these measures are reported.
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: 97 patients were consented to participate but 74 of them were screen failed afterward due to not meeting angiographic, laboratory or other inclusion criteria. Hence, patients who were screened, but did not complete the study, were not considered enrolled
Overall Study
| Stage | Atorvastatin 80 mg | Placebo Oral Tablet | Screening |
|---|---|---|---|
| STARTED | 12 | 11 | 74 |
| COMPLETED | 12 | 11 | 0 |
| NOT COMPLETED | 0 | 0 | 74 |
Reasons for not completing this period:
| Reason | Atorvastatin 80 mg | Placebo Oral Tablet | Screening |
|---|---|---|---|
| did not meet final inclusion criteria | 0 | 0 | 74 |
Analysis population for the primary outcome, as defined in the registry: Study closed due to slow recruitment and data was not analyzed. Collected data is no longer available as retention period has passed and investigator has left the institution.
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.
Population: Study terminated by previous investigator due to slow enrollment. Database no longer available. Data report based on IRB termination report; only gender, race data avail. 97 screened, 23 reported as completed study. Screening data as avail reported herein.
| Characteristic | Unit | Atorvastatin 80 mg | Placebo Oral Tablet | Screening | Total |
|---|---|---|---|---|---|
| Participants analysed | 0 | 0 | 97 | 97 | |
| Age, Customized: Age >18 yrs | Participants | 0 | 0 | 97 | 97 |
| Sex: Female, Male: Female | Participants | — | — | 23 | 23 |
| Sex: Female, Male: Male | Participants | — | — | 74 | 74 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | — | — | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | — | — | 96 | 96 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | — | — | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | — | — | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | — | — | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | — | — | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | — | — | 5 | 5 |
| Race (NIH/OMB): White | Participants | — | — | 85 | 85 |
| Race (NIH/OMB): More than one race | Participants | — | — | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | — | — | 7 | 7 |
| Region of Enrollment: United States | participants | — | — | 97 | 97 |
6. Primary Endpoint
The registry lists the primary outcome as Peri-procedural Myonecrosis, measured over 24 hours.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was peri-procedural myonecrosis assessed using troponin T. Troponin is a marker of injury to heart muscle; measuring it after PCI was intended to capture injury occurring around the procedure. The registry describes measurement at 18-24 hours after PCI, with the primary outcome timeframe also listed as 24 hours. It refers both to a quantitative troponin level and to elevation in troponin T, so the record does not fully clarify whether the primary comparison was intended to emphasize a continuous concentration, a threshold-defined event, or both.
As a general statistical concept, a continuous measurement retains information about the range of observed values, while classifying a measurement as elevated or not elevated reduces it to categories defined by a threshold. The endpoint description mentions an assumed event rate and a relative reduction in elevation, whereas the study summary calls the primary endpoint a quantitative troponin level and describes a difference in troponin level. The registry record does not provide a fuller endpoint definition, the threshold for elevation, or a specification of which summary measure would be used.
Troponin was selected as a quantitative marker of procedure-associated heart-muscle injury. Other planned measures included CK and CK-MB, changes in CRP from baseline, and myocardial perfusion measures. These are listed as secondary outcomes or interests, not as analyzed findings. The registry record states that the study closed due to slow recruitment and that data were not analyzed. No troponin values, event counts, treatment contrast, confidence interval, or significance test are reported. Consequently, the endpoint's intended role can be described, but its results cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The principal statistical fact is the absence of an analyzed primary outcome. The registry says that recruitment was slow, the study was closed, and collected data were no longer available after the retention period had passed and the investigator had left the institution. It therefore reports no troponin T summary by treatment group and no estimate of the effect of atorvastatin relative to placebo. There is no reported confidence interval or hypothesis-test result from which to assess the direction, magnitude, or precision of a treatment contrast.
Enrollment was 97, while the study summary described an intended enrollment of 150 participants, with 75 per group. These are different kinds of information: the first is the enrollment recorded for the trial, and the latter is the planned target. The record does not state how many of the enrolled participants were randomized, how many received study medication, or how many contributed an endpoint measurement. It would therefore be inappropriate to treat enrollment as the analyzed sample size or assume equal allocation was achieved.
The design description says the study was powered to detect a 30% difference in troponin level. The primary outcome description instead states an assumption of a 40% troponin T elevation event rate and a target of predicting a 30% relative reduction. These descriptions express planning aims. They do not show that the trial achieved its planned precision, and the record does not report a completed analysis that could confirm or refute either target. A target effect is not an observed effect.
The registry lists secondary outcome topics, but does not report analyzed results for them. In particular, it provides no group summaries for CK, CK-MB, CRP, or perfusion measures. There is also no reported accounting of missing endpoint measurements, no analysis population definition, and no description of how the planned endpoint was to be modeled. Because the data were not analyzed, there is no posted estimate to recalculate or compare with a sponsor analysis.
Any sample-size illustrations associated with trial results should be read as planning exercises, not as evidence of achieved power or treatment benefit. General planning calculations depend on assumptions about effect size, variability or event frequency, significance level, allocation, and analysis method. The original design statements offer some planned targets, but the registry record does not provide enough detail to establish every assumption or to reconstruct a complete justification. The early termination and unavailable data mean that neither a null result nor a favorable result can be inferred. The statistical conclusion is limited to the fact that the intended treatment comparison was not reported as analyzed.
9. Statistical Methods Explained
Randomization is intended to create treatment groups that are comparable, on average, with respect to both measured and unmeasured characteristics. If allocation is implemented as planned and outcomes are analyzed appropriately, differences between groups can support an estimate of the intervention contrast. In this study, the registry describes random assignment to atorvastatin or placebo, but gives no randomized group counts, allocation procedure details, or analysis results. The description of randomization is therefore evidence of the intended design, not evidence that a particular balance or treatment effect was observed.
Placebo control means that the comparator was designed to resemble an inactive treatment, helping separate the effect of the active intervention from changes associated with receiving a tablet or participating in a trial. Quadruple masking indicates that the study was described as masked across four roles, but the registry record does not identify those roles or report whether masking was maintained. Masking and randomization are features of design; neither substitutes for results, and neither establishes that outcome assessment or analysis was free from bias.
The primary endpoint was planned as troponin T measured 18-24 hours after PCI. A quantitative endpoint can be summarized by a measure of central tendency and a measure of spread, then compared between groups. A threshold-defined endpoint instead records whether a participant meets a specified definition of elevation; that kind of outcome is often summarized as event counts or proportions and compared using a suitable categorical model. The registry uses both quantitative-level language and event-rate language. It does not report the threshold, planned summary measure, statistical model, or a detailed analysis specification. That leaves uncertainty about the exact estimand: the specific treatment contrast the analysis was intended to estimate.
A confidence interval, as a general concept, expresses a range of values compatible with the data and the assumptions of the analysis. Its width reflects precision: less information or greater variability generally produces a wider interval. A confidence interval around a treatment contrast would have helped readers assess which effect sizes remained plausible. No such interval is reported, because the primary outcome was not analyzed. There is also no reported p-value. Neither the lack of a reported p-value nor the lack of an estimate should be interpreted as evidence that the treatments were equivalent.
The registry describes the study as powered to detect a 30% difference and separately mentions an assumed 40% event rate with a predicted 30% relative reduction in troponin T elevation. In general, power is the probability that a specified analysis will reject a null hypothesis under a particular assumed effect and other design conditions. It is a planning quantity, not a property observed after a study ends. The record does not give a complete account of the assumptions behind its planned target, nor does it state that the target was reached. With early closure and no endpoint analysis, no observed power can be inferred. A post hoc calculation based on a missing observed effect would not establish what the study could reliably detect.
Over-dispersion is a general concern for count outcomes when variation is greater than expected under a simple statistical model. If present, it can make standard errors too small and confidence intervals too narrow unless the model accounts for that extra variability. The primary endpoint is described as troponin concentration and elevation rather than a count of recurrent events, so the record does not establish that over-dispersion is relevant to its primary analysis. For any biomarker or event outcome, the appropriate model would depend on the endpoint distribution and the planned estimand. The registry record does not report model diagnostics or a modeling plan.
Multiplicity arises when several outcomes, time points, subgroups, or tests are considered. Conducting many tests can increase the chance of at least one apparently notable result by chance. The registry lists secondary outcomes involving CK and CK-MB, CRP, and perfusion, in addition to the primary troponin endpoint. It does not report a hierarchy of testing, a multiplicity adjustment, or whether any secondary analyses were planned as confirmatory or exploratory. Since there are no reported analyses, the impact of multiplicity on results cannot be assessed.
Missing data methods matter when participants lack an endpoint measurement or leave follow-up. An analysis may depend on whether such missingness is uncommon, related to observed information, or related to unobserved outcomes. The registry states that the collected data were no longer available and that the data were not analyzed. It does not report participant-level outcome completeness, reasons for missing measurements, or an approach to missing data. This is different from a routine analysis in which some individual measurements are missing but the rest of the dataset remains available; the registry describes a broader inability to analyze the collected data.
Analysis populations also affect interpretation. An intention-to-treat analysis generally compares participants according to randomized assignment, while a per-protocol analysis focuses on those meeting specified adherence criteria. These are general approaches, not claims about the trial's actual analysis. The registry does not report a defined analysis population, treatment received, adherence, or randomized counts. No estimate can be attributed to an intention-to-treat or per-protocol population. The study's early closure, unavailable dataset, and absent analysis plan details limit what can be concluded beyond the planned comparison and endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary troponin T outcome and several secondary outcome topics: CK and CK-MB, CRP, and myocardial perfusion measures. When a study tests multiple outcomes or analyses, multiplicity can make chance findings more likely unless the testing strategy is prespecified and interpreted accordingly. As a general statistical principle, a testing hierarchy or adjustment can help control this issue, while clearly labeling secondary analyses as exploratory can help readers understand their evidential status. The registry record does not report a multiplicity strategy, the order of testing, or a distinction between confirmatory and exploratory secondary outcomes.
There are no reported analysis results for the primary or secondary outcomes. No confidence intervals, p-values, effect estimates, group summaries, or endpoint counts are given. Consequently, it is not possible to assess whether a multiplicity adjustment was applied in practice or how it might have affected any conclusion. The number of outcome measures listed is not a substitute for knowing which tests were actually performed.
The registry says the study closed because recruitment was slow and that data were not analyzed. It further states that collected data were no longer available because the retention period had passed and the investigator had left the institution. Participant-level missingness, outcome completeness, withdrawal counts, and reasons for missing endpoint data are not reported in the registry record. No missing-data method is described.
The record does not identify an intention-to-treat, per-protocol, or other analysis population, and it gives no randomized or treated group sizes. Thus, the 97 enrolled participants cannot be assumed to be the number randomized or analyzed. The absence of an analysis population definition and outcome data prevents reconstruction of the treatment comparison, but does not establish that any particular form of missingness or bias occurred.
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 |
|---|---|---|---|
| Screening | 4 | 97 | 4.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Atorvastatin 80 mg | 0 of 0 |
| Placebo Oral Tablet | 0 of 0 |
| Screening | 2 of 97 |
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 |
|---|---|
| Atorvastatin 80 mg | 0 of 0 |
| Placebo Oral Tablet | 0 of 0 |
| Screening | 0 of 97 |
Most frequent serious adverse event terms
| Event term | Organ system | Atorvastatin 80 mg | Placebo Oral Tablet | Screening |
|---|---|---|---|---|
| staged revasculalrization | Cardiac disorders | 0 of 0 | 0 of 0 | 1 of 97 |
| increasing shortness of breath | Respiratory, thoracic and mediastinal disorders | 0 of 0 | 0 of 0 | 1 of 97 |
| intracranial hemmorhage | Nervous system disorders | 0 of 0 | 0 of 0 | 1 of 97 |
| cardiorespiratory arrest | Cardiac disorders | 0 of 0 | 0 of 0 | 1 of 97 |
Serious events with the highest arm-level rate: staged revasculalrization (1.0%), increasing shortness of breath (1.0%), intracranial hemmorhage (1.0%), cardiorespiratory arrest (1.0%).
The registry’s adverse-event figures require particular care because the two randomized treatment groups list zero participants at risk. For both Atorvastatin 80 mg and Placebo Oral Tablet, the record lists zero at risk for serious and other adverse events, with zero affected and zero deaths. With no participants recorded as at risk in those groups, these entries cannot be read as showing that no adverse events occurred among treated participants. They do not provide a usable treatment-group safety comparison.
The Screening group lists 97 participants at risk, 4 affected by serious adverse events, zero affected by other adverse events, and 2 deaths. These are screening-group figures in the registry record. The record does not establish that all these participants were randomized or received either study intervention, so the counts should not be attributed to atorvastatin or placebo. The listed serious-event terms are staged revasculalrization, increasing shortness of breath, intracranial hemmorhage, and cardiorespiratory arrest; each is reported as 1.0%. The record does not identify the treatment group for these terms or provide further case details.
Adverse-event counts describe events recorded in a specified group; they do not by themselves establish that an intervention caused an event. Interpretation ordinarily depends on exposure, timing, event definitions, ascertainment, and comparison groups. These details are not reported in the registry record. The figures therefore document what was entered for the screening cohort but do not support a comparative safety estimate for the randomized interventions.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study’s intended question and design: a randomized comparison of one pre-procedure 80 mg dose of atorvastatin against placebo, with troponin T at 18-24 hours after PCI as the principal measure of peri-procedural myonecrosis. It also documents enrollment of 97 participants, a terminated status, and an explanation that recruitment was slow. Most importantly for interpretation, it states that the collected data were not analyzed and were no longer available.
Accordingly, the record does not show whether the troponin measurements differed between the groups, how large any difference might have been, or how precisely it could be estimated. It does not establish that the treatment groups were similar or different. It also does not provide analyzed results for the secondary outcomes. Without an estimate and uncertainty interval, readers cannot judge whether results would have been compatible with a small effect, a larger effect, or no meaningful difference under the planned comparison.
The stated design target should not be mistaken for a finding. The planned 30% difference or relative reduction and the assumed event rate describe what the study intended to detect under its design assumptions. They do not say what happened to participants. Likewise, the enrollment figure does not reveal the number randomized, the size of either treatment group, endpoint completion, or analysis population.
The adverse-event entries also do not resolve the efficacy question. The randomized arms show zero participants at risk in the posted adverse-event figures, while the screening group carries the listed counts. Those entries cannot be used to compare safety between atorvastatin and placebo. More broadly, neither an absence of analyzed results nor incomplete registry information demonstrates that the intervention was effective, ineffective, safe, or unsafe. The defensible conclusion is that the planned clinical comparison is unresolved in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between a registered research question and an answer supported by analyzed data. A carefully described randomized design can specify a population, intervention, comparator, and endpoint, but it cannot yield an effect estimate if the outcome data are not analyzed or available. Readers need results and their uncertainty to evaluate what a trial contributes statistically.
The record also shows why planned sample size and enrollment should not be conflated. The study summary describes a target of 150 participants, with 75 per group, while the registry records enrollment of 97. The record does not state how many participants were randomized or analyzed. A stated target does not guarantee that it was reached, and a count of enrolled participants alone does not reveal the information available for an endpoint comparison. The target effect and assumed event rate are planning assumptions, not observations.
The endpoint description contains both quantitative troponin language and a threshold-event framing. Clarity about the estimand and analysis method matters because a difference in mean or distribution of concentrations is not identical to a difference in the probability of crossing a threshold. The registry does not provide the detail needed to determine exactly how these descriptions would have been reconciled in an analysis.
Finally, the record makes transparent that recruitment ended early and that the collected data could no longer be analyzed. This limits conclusions but does not turn the missing result into evidence for either treatment. Statistically, the key lesson is to separate study intent, enrollment, analysis, and inference. Only an analyzed comparison with an interpretable measure of uncertainty could answer the clinical question the trial set out to address.
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 most consequential limitation is explicit: the study closed because of slow recruitment, the data were not analyzed, and the collected data were no longer available after the retention period had passed and the investigator had left the institution. There is therefore no reported primary outcome estimate, secondary outcome analysis, confidence interval, or significance test. This prevents assessment of effect size, precision, direction, or compatibility with a null effect.
The registry records enrollment of 97 but does not report the number randomized, the numbers assigned to each arm, the number exposed to study medication, or the number with an 18-24 hour troponin measurement. The planned enrollment of 150, with 75 per group, was not the recorded enrollment. Without participant flow and analysis counts, the enrolled total cannot be treated as the analyzed sample or as proof that randomization occurred in equal groups.
The outcome definition is not fully specified. The primary endpoint is described as a quantitative troponin level, while the description also refers to a troponin T elevation event, an assumed event rate, and a relative reduction. The threshold for elevation, intended summary measure, and analysis model are not reported in the registry record. It also gives different descriptions of the average timing before PCI: the study summary says an average of 4 hours with at least 2 hours, while the arm descriptions say an average of 2-4 hours.
Details of the randomization procedure, masking roles, adherence, protocol deviations, missing measurements, analysis population, interim analyses, and multiplicity handling are not reported in the registry record. The adverse-event entries do not provide an interpretable randomized-arm comparison because both treatment arms list zero at risk. These limitations do not establish a particular bias or clinical outcome; they mark what cannot be determined from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effects of Atorvastatin on Myonecrosis — NCT00344019.
- Registry record last updated 2018-01-02; status last verified 2017-12.
- Results first posted 2017-07-02.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00344019, Effects of Atorvastatin on Myonecrosis, was a Phase 4 randomized, placebo-controlled, quadruple-masked, parallel-group study sponsored by Beth Israel Deaconess Medical Center. It planned to compare a single 80 mg dose of atorvastatin before PCI with oral placebo in patients with acute coronary syndromes. The primary endpoint was peri-procedural myonecrosis assessed by troponin T at 18-24 hours after PCI. Planned secondary measures included CK, CK-MB, CRP, and myocardial perfusion.
The registry lists enrollment of 97, a start date of 2006-05, primary completion in 2008-10, and terminated status. The record says the study closed due to slow recruitment, the data were not analyzed, and the collected data were no longer available. It reports no primary or secondary treatment-effect estimates. The stated target of 150 participants, with 75 per group, and the planned effect assumptions are design information, not observed results. The record therefore documents an unanswered treatment comparison rather than evidence for or against a difference between the interventions.