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 Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation (NCT02132767), a randomized phase 3 study. The primary outcome is Total Number of Days in Hospital.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02132767 |
| Phase | Phase 3 |
| Condition | Postoperative Atrial Fibrillation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 523 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing cardiac surgery who develop in-hospital postoperative atrial fibrillation or atrial flutter. The primary outcome population is described as all randomized patients, analyzed by intent to treat.
Intervention
A rhythm-control strategy using amiodarone and/or DC-cardioversion. The registry describes both oral and intravenous amiodarone approaches; the precise treatment depended on clinical circumstances.
Comparator
A rate-control strategy using beta-blockers and/or calcium channel blockers and/or digoxin, with dose, frequency, and duration determined by a medical professional as medically needed.
Primary question
Among patients with postoperative atrial fibrillation or flutter, does assignment to rhythm control rather than rate control change the total number of days in hospital for any hospitalization within 60 days of randomization?
The clinical question concerns two treatment strategies, not a comparison of a single fixed drug against another fixed drug. The registry's intervention descriptions allow for more than one medication or procedure within each strategy. That makes the result relevant to the overall assigned approach as it was implemented in the trial, rather than to the isolated effect of a particular component.
The registry describes the study hypothesis as expecting rhythm control to reduce hospital days within 60 days of the occurrence of atrial fibrillation. The primary outcome definition instead specifies the 60-day period after randomization. These descriptions are not identical in their time origin. The posted primary outcome's timeframe and definition are the basis for interpreting the reported result; the registry record does not explain the difference between the two wordings.
The comparison is clinically and statistically about the distribution of hospital days after assignment. It does not, by itself, resolve questions about every feature of recovery, rhythm, treatment burden, or safety. Those topics are represented by secondary outcomes and adverse-event reporting, whose detail and analysis have their own limitations.
3. Trial Design
This was a phase 3, randomized, parallel-group trial with no masking. The registry lists enrollment of 523 and identifies the study as completed. The record lists a start date of 2014-05 and primary completion of 2015-09. The sponsor was Icahn School of Medicine at Mount Sinai.
Participants were assigned to rate control or rhythm control after developing postoperative atrial fibrillation or atrial flutter during hospitalization following cardiac surgery. The two groups reflect strategy assignment. Rhythm control could involve amiodarone and/or DC-cardioversion; rate control could involve beta-blockers, calcium channel blockers, and/or digoxin. The registry describes clinician-determined dosing for rate control. The available rhythm-control arm description includes an amiodarone regimen but ends before giving the full maintenance-dose details, so the complete regimen is not reported in the registry record.
The posted primary endpoint is the total number of days in hospital for any hospitalization within 60 days of randomization. The registry identifies its population as all randomized patients analyzed by intent to treat. It reports median hospital days and inter-quartile ranges separately by arm, and a Wilcoxon (Mann-Whitney) comparison between arms.
The primary outcome results list 262 participants for rate control and 261 for rhythm control. The reported medians are 5.1 days and 5.0 days, respectively. The inter-quartile ranges are 3.0 to 7.4 days for rate control and 3.2 to 7.5 days for rhythm control. The sponsor-reported comparison has p = 0.76.
The registry record does not report details of sequence generation, allocation concealment, eligibility criteria, site count, protocol deviations, or adherence to assigned strategies. It also does not explain whether treatment changes or crossovers occurred. These details would help readers assess how the randomized strategy comparison was conducted and how closely it reflects treatment actually received.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Rate Control | Rhythm Control |
|---|---|---|
| STARTED | 262 | 261 |
| COMPLETED | 245 | 246 |
| NOT COMPLETED | 17 | 15 |
Reasons for not completing this period:
| Reason | Rate Control | Rhythm Control |
|---|---|---|
| Death | 3 | 2 |
| Withdrawal by Subject | 10 | 9 |
| Lost to Follow-up | 4 | 4 |
Analysis population for the primary outcome, as defined in the registry: All randomized patients (intent to treat)
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: All randomized patients
| Characteristic | Unit | Rate Control | Rhythm Control | Total |
|---|---|---|---|---|
| Participants analysed | 262 | 261 | 523 | |
| Age, Continuous | years | 69.2 (SD 9.8) | 68.4 (SD 8.4) | 68.8 (SD 9.1) |
| Sex: Female, Male: Female | Participants | 65 | 62 | 127 |
| Sex: Female, Male: Male | Participants | 197 | 199 | 396 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 | 12 | 22 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 252 | 249 | 501 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Asian | Participants | 13 | 3 | 16 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 5 | 10 |
| Race (NIH/OMB): White | Participants | 242 | 250 | 492 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 2 |
| Region of Enrollment: Canada | participants | 32 | 29 | 61 |
| Region of Enrollment: United States | participants | 230 | 232 | 462 |
6. Primary Endpoint
The registry lists the primary outcome as Total Number of Days in Hospital, measured over Within 60 days of randomization.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint counts the total number of days a participant spent in hospital for any hospitalization occurring within 60 days of randomization to a postoperative atrial fibrillation treatment strategy. It therefore captures hospital use over a defined follow-up period, rather than only the length of the initial surgical admission. The registry labels the measure as a median and reports its inter-quartile range.
Hospital days can be a useful outcome because they summarize time spent in hospital across the period of interest. In this trial, counting any hospitalization makes the measure broader than index-hospital length of stay alone. The registry also lists index hospitalization and rehospitalization as secondary outcomes, suggesting that these aspects were considered separately as well. The record does not give a clinical rationale for selecting this endpoint over other outcomes.
A median describes the middle of an outcome distribution, while the inter-quartile range describes the middle half of the observed values. These summaries are useful when a distribution is not well represented by a mean and standard deviation, including when values are skewed. They do not show every individual participant's hospital use, nor do they alone quantify the uncertainty in the difference between groups.
The primary outcome timeframe is within 60 days of randomization. The brief study summary refers to days in hospital within 60 days of the occurrence of atrial fibrillation, a different stated time origin. The registry record does not clarify this wording difference. The interpretation of the posted primary result therefore follows its explicit outcome definition and timeframe.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results describe similar median hospital-day values in the two randomized groups: 5.1 days for rate control and 5.0 days for rhythm control. The inter-quartile ranges overlap substantially, with values of 3.0 to 7.4 days and 3.2 to 7.5 days, respectively. The sponsor-reported Wilcoxon (Mann-Whitney) test gives p = 0.76. These data do not provide evidence of a difference in the distributions of hospital days using that test.
A p-value is a measure of how compatible the observed data are with a specified null hypothesis under the assumptions of the analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. A large p-value does not prove that the strategies are equivalent. Establishing equivalence or non-inferiority requires an appropriate design, a prespecified margin, and an analysis suited to that question; those details are not reported in the registry record.
The registry reports separate medians and inter-quartile ranges, but it does not report a confidence interval for the between-group contrast in this primary outcome. Without that interval or another measure of uncertainty for the contrast, readers cannot use the primary result to identify a range of effects compatible with the data. The group summaries indicate the observed distributions' centers and middle spreads, but do not provide a direct estimate with precision for the difference between strategies.
The test is rank-based, comparing the relative ordering of observations rather than directly testing a difference between the two medians in isolation. Its result should therefore be understood as a comparison of outcome distributions. A p-value alone cannot reveal whether any difference, if present, is concentrated in a particular part of the distribution or whether it would matter clinically.
The secondary outcomes address other aspects of rhythm, hospitalization, outpatient interventions, and AF- or treatment-related events. They may add context, but they do not replace the primary comparison. The registry lists 9 posted secondary outcomes and 8 analyses, while the primary endpoint remains the principal basis for interpreting the trial's stated hospital-days question. The available record does not set out how secondary findings were prioritized or whether any were adjusted for multiple testing.
Overall, the posted primary result is an absence of a statistically significant difference in the reported analysis, not proof that the approaches have identical effects. The modest separation in the displayed medians is only a descriptive comparison and should not be treated as an estimated treatment effect with known precision. Interpretation is constrained by the lack of a reported confidence interval, by uncertainty about the distinction between the summary's and endpoint's time origins, and by the limited methodological detail in the registry record.
9. Statistical Methods Explained
The primary endpoint is a count of hospital days summarized by its median and inter-quartile range. A median is the central observation when values are ordered. The inter-quartile range spans the central half of the observed values. These summaries can be informative when hospital days are unevenly distributed, because a small number of participants with long stays need not pull the median in the way they can affect a mean. In this trial, the registry reports the median and inter-quartile range for each randomized group.
What does the Wilcoxon (Mann-Whitney) test compare?
The Wilcoxon (Mann-Whitney) test is a rank-based method for comparing two independent groups. It orders participants' outcome values and evaluates whether values in one group tend to rank higher or lower than values in the other. It does not require the analyst to compare only the group medians, and a significant result would not automatically mean that the median difference alone explains the result. Interpreting it as a test of a pure location shift relies on additional assumptions about the shapes of the group distributions.
The registry reports this test for the primary outcome and gives p = 0.76. A p-value summarizes compatibility with the null hypothesis under the test's assumptions; it is not a measure of effect size or precision. A confidence interval for a contrast would address precision more directly. No primary contrast estimate or confidence interval is reported in the registry record, so the p-value should not be made to stand in for one.
Why might rank-based methods suit hospital days?
Hospital-day outcomes are counts and may have an uneven distribution, with many participants having similar or short stays and some having longer stays. A rank-based comparison can be useful when a normal-distribution model for the raw values is not a good fit. That is a general statistical reason such a method may be considered; the registry record does not state why the sponsor selected it or report distributional diagnostics.
Over-dispersion is a general term for variability greater than a simple model assumes. For count outcomes, over-dispersion can make model-based standard errors too small if the model does not account for it. The posted primary analysis is rank-based rather than a count regression, and the registry does not report a model assessing over-dispersion. This concept is relevant to some ways of analyzing counts, but it should not be presented as a finding about these data.
How should the secondary binary comparison be understood?
The posted Heart Rhythm Comparison at hospital discharge is represented as a participant count and analyzed in the sponsor's report with a chi-squared test. A chi-squared test is a general method for assessing whether categorical outcomes differ between groups. The registry reports a sponsor p-value of 0.14 for that comparison. The unadjusted recalculation gives a risk difference of 0.036, with its confidence interval extending from -0.011 to 0.084, and an unadjusted p-value of 0.137. These are unadjusted summaries; they do not account for other outcome tests or covariates.
A risk difference expresses the difference between group proportions on an absolute scale. Its confidence interval describes a range of values compatible with the data and the calculation's assumptions. If an interval includes zero, values corresponding to no difference are among those compatible values. That does not establish that the true difference is zero. The registry's sponsor-reported test and the recalculated estimate are distinct analyses, so they should be read according to their stated methods rather than treated as interchangeable outputs.
What do planning illustrations mean?
Planning illustrations based on an observed effect describe hypothetical sample sizes under stated assumptions. The assumptions for these illustrations include a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The rows consider detecting specified fractions of the observed effect. These are planning scenarios, not the trial's original sample-size justification, which is not reported in the registry record.
Participants per arm for 80% power or for 90% power are not observed power and do not indicate the probability that the trial's result is correct. Such calculations depend on the assumed effect, variability or event frequency, allocation, significance threshold, and analysis method. When the observed effect is uncertain, planning directly from it can produce unstable illustrations. The record does not report the assumptions used for the original trial design or a formal sample-size calculation.
For time-to-event outcomes, the general Schoenfeld approach uses the total number of events in a planning calculation. The registry's planning note distinguishes that approach from other outcomes, for which the illustration gives participants per arm. These are general planning conventions, not evidence about how the trial itself was designed. The registry record does not report a sponsor time-to-event hazard-ratio analysis among the results described in this comparison.
Across all methods, the key distinction is between a descriptive summary, a test, an estimate, and a planning scenario. The medians describe each group; the Wilcoxon p-value gives a test result; a contrast and confidence interval would quantify the between-group effect and its precision; and sample-size illustrations explore hypothetical future planning. They answer different questions and should not be substituted for one another.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Wilcoxon (Mann-Whitney) | not reported | 0.760 |
For the primary outcome, the registry reports the sponsor's Wilcoxon (Mann-Whitney) comparison with p = 0.76. No sponsor estimate or confidence interval for the between-group contrast is reported. The medians and inter-quartile ranges give group-level descriptions, while the reported p-value is the result of the sponsor's test. They do not together yield a confidence interval for the primary contrast.
The sponsor's analysis of the posted Heart Rhythm Comparison at hospital discharge uses a chi-squared test and reports p = 0.14. An unadjusted recalculation from the posted counts gives a risk difference of 0.036, a confidence interval from -0.011 to 0.084, and p = 0.137. The recalculation is a simple unadjusted analysis and is not a replacement for the sponsor's stated test. The p-values are close, but the registry does not explain their precise relationship or report a discrepancy for this comparison.
These summaries answer related but not identical questions: a chi-squared test evaluates a categorical association, while the recalculated risk difference expresses the absolute difference in proportions and supplies an interval for that contrast. The interval includes values corresponding to no difference, as well as values on either side. Neither summary alone establishes equivalence or resolves the clinical importance of possible effects. For the primary endpoint, the sponsor's reported test remains the available inferential result; an unadjusted recalculation is not available for the median-time comparison.
11. Multiplicity, Missing Data and Analysis Populations
The registry identifies the primary outcome population as all randomized patients analyzed by intent to treat. This indicates that the stated primary analysis is based on randomized assignment rather than treatment actually received. The registry does not report further details about the implementation of the intent-to-treat analysis, including how missing primary outcome data were handled or whether any participants were excluded from the posted analysis.
The record does not report the extent or reasons for missing data, methods for imputation, sensitivity analyses, or a missing-data assumption. The primary results list group sizes, but these alone do not explain whether every randomized participant contributed complete outcome information. The record also does not report protocol deviations, crossovers, or how these might have been handled analytically.
Multiplicity is relevant because the registry lists multiple secondary outcomes and analyses. If many hypotheses are tested, a nominal p-value for a secondary result can overstate the strength of evidence when read without considering the full set of tests. A prespecified hierarchy, adjustment method, or clear separation of confirmatory and exploratory analyses can help readers understand the intended evidential role of each result. Such a plan is not reported in the registry record.
The registry does not report a statistical analysis plan, interim analyses, stopping rules, or a sample-size justification for the trial. The planning illustrations based on observed effects are not a substitute for those design details. Without the original assumptions and procedures, readers cannot determine from the registry record whether the trial was designed to detect a particular clinically important difference, or how the sponsor intended to control error across outcomes.
These absences do not demonstrate that the study lacked such procedures; they mean the procedures are not reported in the registry record. They limit independent assessment of missingness, multiplicity, and analysis decisions. The posted primary comparison can still be described as reported, but conclusions about robustness should remain bounded by the available information.
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 |
|---|---|---|---|
| Rate Control | 71 | 262 | 27.1% |
| Rhythm Control | 73 | 261 | 28.0% |
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 |
|---|---|
| Rate Control | 29 of 262 |
| Rhythm Control | 26 of 261 |
Most frequent serious adverse event terms
| Event term | Organ system | Rate Control | Rhythm Control |
|---|---|---|---|
| Cardiac Arrhythmias | Cardiac disorders | 20 of 262 | 19 of 261 |
| Major Infection | Infections and infestations | 23 of 262 | 16 of 261 |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | 10 of 262 | 19 of 261 |
| Bleeding | General disorders | 10 of 262 | 6 of 261 |
| Heart Failure | Cardiac disorders | 8 of 262 | 7 of 261 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 5 of 262 | 6 of 261 |
| Renal Events | Renal and urinary disorders | 5 of 262 | 5 of 261 |
| Hypotension/Syncope | Cardiac disorders | 5 of 262 | 3 of 261 |
| Chest Pain | Cardiac disorders | 2 of 262 | 5 of 261 |
| Cerebrovascular Thromboembolism | Nervous system disorders | 4 of 262 | 2 of 261 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Rate Control | Rhythm Control |
|---|---|---|---|
| Major infection | Infections and infestations | 17 of 262 | 11 of 261 |
| Cardiac Arrhythmias | Cardiac disorders | 2 of 262 | 7 of 261 |
| Renal events | Renal and urinary disorders | 3 of 262 | 6 of 261 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 5 of 262 | 1 of 261 |
| Bleeding | General disorders | 2 of 262 | 1 of 261 |
| Superficial venous thrombosis | Vascular disorders | 1 of 262 | 0 of 261 |
| Thrombophlebitis left limb | Vascular disorders | 1 of 262 | 0 of 261 |
Serious events with the highest arm-level rate: major infection (8.8%), cardiac arrhythmias (7.6%), pleural effusion (7.3%), bleeding (3.8%), heart failure (3.1%).
The registry reports serious adverse events among 71 of 262 participants in the rate-control group and 73 of 261 participants in the rhythm-control group. It separately reports other adverse events among 29 of 262 and 26 of 261 participants, respectively. These are participant counts, not event rates recalculated for exposure time, and the registry record does not describe the duration or completeness of safety follow-up in these results.
The serious-event terms listed most often include Major Infection at 8.8%, Cardiac Arrhythmias at 7.6%, Pleural Effusion at 7.3%, Bleeding at 3.8%, Heart Failure at 3.1%, and Respiratory Failure at 2.3%. The record does not specify in this listing how these terms are distributed between the two groups. They should therefore not be interpreted as arm-specific comparisons.
Adverse-event counts are descriptive safety information. They do not, on their own, establish that an event was caused by the assigned strategy, nor do they account for differences in duration, severity, or exposure. Death counts are not reported in the registry record. These safety data provide context but are not a substitute for a detailed safety analysis or a causal comparison.
13. What the Result Does, and Does Not, Mean
The primary result shows that the registry's reported rank-based analysis did not identify a statistically significant difference in hospital-day distributions between the randomized strategies. The group medians are close, and the inter-quartile ranges overlap. These observations describe the posted results; they do not prove that the strategies have identical effects or that any possible difference is clinically unimportant.
A non-significant result can arise when the true effect is small, when the data are imprecise, or under other circumstances. Without a confidence interval for the primary contrast, the registry result does not show a range of effect sizes compatible with the data. The p-value is not a measure of the probability that there is no difference, nor is it evidence of equivalence. The record does not report an equivalence or non-inferiority framework.
The result applies to the randomized strategies described in this registry record, in the studied population of cardiac-surgery patients with postoperative atrial fibrillation or flutter. It should not automatically be generalized to other populations, settings, or specific treatment regimens. The strategy arms allowed combinations of treatments, and the record does not fully document treatment received, adherence, or crossover.
The primary endpoint captures hospital days across any hospitalization within the stated follow-up window. It does not fully characterize rhythm control, quality of life, treatment burden, or every other clinical outcome. Secondary endpoints and adverse-event counts offer additional information, but the registry's reporting limitations and the potential for multiple comparisons affect how strongly those findings can be interpreted.
The registry contains a difference between the time origin in its brief summary and the explicit primary outcome definition: the summary refers to 60 days from atrial fibrillation occurrence, while the endpoint states 60 days from randomization. The record does not clarify this distinction. The posted primary outcome should be interpreted according to its stated definition, while recognizing that the wording leaves an unresolved ambiguity.
14. Why This Trial Matters Statistically
This trial illustrates an important distinction in clinical research: a randomized comparison of treatment strategies can yield a non-significant primary test without establishing that the strategies are equivalent. The reported p = 0.76 is evidence about compatibility with the null hypothesis under the sponsor's selected test, not a direct measure of how large or small the treatment contrast could be.
It also demonstrates why group summaries and inferential estimates are not interchangeable. Medians and inter-quartile ranges describe the observed distributions, while a test evaluates a hypothesis and a confidence interval would communicate uncertainty around a defined contrast. The primary registry results include the former and the test, but do not report a confidence interval for the primary between-group effect. That limits how precisely readers can assess the range of plausible differences.
The comparison is between clinical strategies that permit multiple treatment components, not single standardized regimens. This is often the relevant question for pragmatic decision-making, but it makes the result a comparison of assigned approaches as implemented. Missing information about adherence and crossovers constrains interpretation of the treatment actually received.
Finally, the registry lists secondary outcomes and adverse events alongside the primary endpoint. Their value depends on transparent analysis plans, complete reporting, and appropriate caution about multiplicity. The record's unadjusted secondary comparison illustrates how an estimate, confidence interval, and p-value can offer different perspectives on the same data. Taken together, the trial is a useful case for separating the clinical question, the endpoint, the statistical test, and the strength of the conclusion.
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 primary result has no reported confidence interval or effect estimate for the between-group contrast. The reported medians and inter-quartile ranges give descriptive information, but they do not show the precision of a treatment contrast. The p-value alone cannot establish equivalence, quantify clinical importance, or show what effects remain compatible with the data.
The registry uses different time-origin wording in the brief summary and the primary outcome definition. The summary refers to the period after atrial fibrillation occurs, whereas the endpoint specifies the period after randomization. The record does not explain how these descriptions relate or whether the endpoint wording reflects the operational analysis.
The registry record does not report the original sample-size justification, full statistical analysis plan, missing-data methods, interim analyses, or multiplicity strategy. It also does not report allocation-concealment details, protocol deviations, treatment adherence, or crossovers. These gaps limit assessment of design decisions and robustness.
The intervention arms are strategies that permit multiple medications or procedures, and the rhythm-control description is incomplete in the registry text. The result therefore cannot isolate the effect of a specific component or fully characterize the regimens used. The available results also do not establish how treatment varied across clinicians or participants.
Finally, the secondary outcomes cover different constructs and are not reported with a common synthesis. The registry's adverse-event listing does not specify arm allocation for the listed serious-event terms, and deaths are not reported. Safety interpretation is consequently descriptive and limited to the reported participant counts and terms.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation — NCT02132767.
- Registry record last updated 2019-03-15; status last verified 2019-02.
- Results first posted 2017-01-18.
- 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.
19. Record Summary
NCT02132767 is a completed, phase 3, randomized, parallel-group trial with no masking. It compared rate-control and rhythm-control strategies in cardiac-surgery patients who developed in-hospital postoperative atrial fibrillation or atrial flutter. The registry lists enrollment of 523, a start date of 2014-05, primary completion of 2015-09, and Icahn School of Medicine at Mount Sinai as sponsor.
The primary endpoint was total hospital days for any hospitalization within 60 days of randomization, summarized by medians and inter-quartile ranges. The sponsor reported a Wilcoxon (Mann-Whitney) comparison with p = 0.76. The registry does not report a confidence interval for the primary contrast. Secondary outcomes and adverse-event counts add context, but incomplete methodological and reporting detail limits their interpretation.