Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome (NCT02252406), a randomized phase 4 study. The primary outcome is Impact of Ranolazine on Hemoglobin A1C.

2. Clinical Question

3. Trial Design

The registry describes a Phase 4, randomized, parallel-group study with quadruple masking. The sponsor was the University of Florida. The study record lists enrollment of 33 and a completed status. The recorded start is 2015-09, and primary completion is listed as 2018-12-17. These details describe the registry entry; they do not establish how many participants contributed data to the primary outcome.

Participants were assigned to ranolazine or placebo, with both groups continuing standard medical therapy. The ranolazine regimen began at 500 mg twice daily and was scheduled for titration to 1 gram twice daily after 3 weeks. The placebo schedule matched that titration. Down-titration was allowed only for side effects in the ranolazine group and for reported side effects in the placebo group. The registry record does not report treatment adherence, dose changes, or the number of participants who completed the full treatment schedule.

Randomization is intended to allocate participants to groups by chance, while masking is intended to limit the influence of knowledge of assignment. The registry label indicates quadruple masking, but the identities of the masked groups or roles are not reported in the registry record. The record describes a parallel design, meaning the assigned groups were followed as separate groups rather than through a planned sequence of treatments. Further details of allocation procedures, concealment, or the timing of any unmasking are not reported in the registry record.

The primary endpoint was mean percent change in hemoglobin A1C from baseline to 24 weeks. Outcome summaries are posted for 9 participants in the ranolazine group and 13 in the placebo group. These outcome counts are not the same as the listed enrollment total, and the reasons for the difference are not reported in the registry record. A sample-size justification, detailed protocol, and statistical analysis plan are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Starting Dose Ranolazine 500 mg BID

Reasons for not completing this period:

Titrated to Ranolazine 1000mg BID

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Impact of Ranolazine on Hemoglobin A1C, measured over Change from baseline to 24 weeks.

The primary endpoint is titled “Impact of Ranolazine on Hemoglobin A1C.” It measures percent change in hemoglobin A1C from baseline to 24 weeks and is summarized as a mean with a standard deviation for each treatment group. Hemoglobin A1C is a blood marker; the study record places it among markers of cardiometabolic disease and specifies its evaluation in women with metabolic syndrome.

A mean describes the central value of the observations in a group. The standard deviation describes how spread out individual values are around that group mean; it is not itself a measure of uncertainty in the mean or a comparison between groups. The posted mean percent change was -5.0 with a standard deviation of 6.2 among 9 participants assigned to ranolazine. In the placebo group, the posted mean was 2.6 with a standard deviation of 9.1 among 13 participants.

In general, a biomarker endpoint can describe a biological measurement without directly establishing a change in symptoms or other clinical outcomes. The registry identifies hemoglobin A1C as the primary outcome but does not report the clinical interpretation threshold, a minimally important difference, or a rationale for selecting this measure. The arm summaries therefore describe the posted biomarker results; by themselves, they do not establish a treatment effect or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is continuous and summarized using a mean and standard deviation. The mean is the arithmetic center of the observed values in a group. The standard deviation describes how dispersed those values are around the mean. A standard deviation is not a confidence interval: it describes variation among observations, whereas a confidence interval describes uncertainty about an estimated quantity, such as a group mean or a difference between groups.

For the primary endpoint, the ranolazine group’s posted mean percent change was -5.0, with a standard deviation of 6.2 and 9 participants. The placebo group’s posted mean was 2.6, with a standard deviation of 9.1 and 13 participants. The measure is defined as change from baseline to 24 weeks. The registry does not report individual observations, a comparative estimate, or a confidence interval for the difference between assigned groups.

What does an arm-level mean tell the reader?

In general, an arm-level mean describes the average outcome among participants included in that group’s summary. It does not account for baseline imbalances, other participant characteristics, or any model-based adjustment unless those are explicitly part of the reported analysis. The registry does not report an adjusted estimate for this endpoint. Thus, the posted values should be treated as descriptive group summaries rather than as an adjusted treatment effect.

In general, a between-group contrast is the quantity that directly compares assigned groups. Its uncertainty depends on the data and the analysis method. Since the registry record does not report the contrast or its uncertainty, neither a confidence interval nor a significance test can be interpreted for the primary comparison. No recalculated comparison is posted in the registry record. The record indicates that values were missing or not estimable for a two-arm comparison of this continuous endpoint, so an unadjusted recalculation is not available.

Why does variability matter?

In general, variability matters because participants’ responses may differ even when they receive the same assigned intervention. A mean alone cannot show whether most observations cluster near that mean or whether the average is influenced by a wider range of values. The standard deviations convey some information about spread, but without distributions or participant-level results, the pattern of individual changes is not known.

In general, over-dispersion means that observed variability is greater than a statistical model expects. When a model assumes less variability than is present, standard errors and resulting uncertainty estimates may be too small. That concept is relevant when a model’s assumptions are being assessed, but the registry does not report a model or an over-dispersion assessment for this continuous endpoint. It would therefore be inappropriate to claim that over-dispersion occurred in this trial.

How should uncertainty be understood?

In general, a confidence interval gives a range of values compatible with the data and the assumptions of the analysis, and communicates uncertainty in an estimate. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. No interval is reported for the primary comparison in the registry record, so the precision of a treatment contrast cannot be described numerically. The arm standard deviations do not substitute for that missing interval.

In general, a p-value is calculated under a specified statistical model and null hypothesis. It does not measure the probability that a treatment works or the probability that the null hypothesis is true. No p-value or test result for the primary comparison is reported in the registry record. Statistical significance therefore cannot be inferred from the signs or apparent separation of the two group means.

What do planning illustrations represent?

In general, sample-size calculations use assumptions about the effect to be detected, variability, significance level, allocation, and statistical method. A planning illustration is a hypothetical design calculation, not an observed trial result and not “observed power.” The record describes its planning assumptions as a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. It also distinguishes participant counts per arm for non-time-to-event calculations. Numerical planning estimates are not reported in the registry record, and these assumptions are not identified as the trial’s original design basis.

A calculation based on an observed effect can be particularly sensitive to the observed estimate and its variability. In general, such an illustration should not be read as evidence that the trial was adequately or inadequately designed. The registry does not report the trial’s sample-size justification, the target effect used when planning enrollment, or a prespecified analysis plan. Those omissions prevent reconstruction of the intended statistical design from the posted summaries.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Ranolazine Treated", "Placebo")
n   <- c(9, 13)
m   <- c(-5, 2.6)
sp  <- c(6.2, 9.1)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Ranolazine Treated  9  -5.000  6.200  -9.766  -0.234
CARM  Placebo  13  2.600  9.100  -2.899  8.099

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and reports no secondary outcome results in this record. It does not report a multiplicity adjustment or a hierarchy specifying how multiple outcomes or analyses were to be interpreted. In general, testing multiple outcomes can increase the chance of at least one apparently notable result, so an analysis plan may specify how to manage that issue. Whether any such plan existed for this trial is not reported in the registry record.

The record lists no posted analyses for this continuous endpoint and indicates that values were missing or not estimable for a two-arm comparison. It does provide the arm-level means, standard deviations, and participant counts. These summaries do not explain why a comparative estimate was not reported. Reasons for unavailable values, participant withdrawal, exclusions, or missingness at the 24-week assessment are not reported in the registry record.

In general, missing-data methods rely on assumptions about why observations are unavailable and how missing participants’ outcomes relate to their observed information. Different assumptions or methods can yield different estimates. The registry does not report a missing-data method, imputation procedure, sensitivity analysis, or a comparison of participants with and without outcome data.

Analysis populations are also important. In general, an intention-to-treat analysis retains participants in their randomized groups, while a per-protocol analysis may focus on participants who followed specified treatment requirements. The registry record does not report which population was used for the posted endpoint summaries or define analysis populations. The outcome counts of 9 and 13 are reported, but why they differ from the enrollment total of 33 is not reported in the registry record. As a result, the summaries cannot be confidently characterized as intention-to-treat, per-protocol, or another analysis population.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 0 serious adverse events among 16 participants at risk in the ranolazine group and 0 among 17 participants at risk in the placebo group. It lists 3 participants with other adverse events among 16 at risk in the ranolazine group and 0 among 17 at risk in the placebo group. The record lists 0 deaths in each group. No serious adverse event terms are listed.

These are descriptive counts for the safety groups identified in the registry. They should not be confused with the primary endpoint counts of 9 and 13, which are the participants included in the hemoglobin A1C summaries. In general, the number at risk indicates the group size used for the safety reporting, while the affected count indicates how many participants were recorded as having the event category. The registry does not report event definitions, timing, severity details for the other adverse events, or whether events were considered related to study treatment.

Zero reported serious events does not establish that the risk of an event is absent. In general, small safety groups and limited observation can leave uncommon events undetected. The registry record does not provide enough detail to assess event rates over time or compare safety statistically. These figures describe what is posted; they do not establish a causal relationship between assignment and an event.

13. What the Result Does, and Does Not, Mean

The posted primary result is a descriptive comparison of mean percent change in hemoglobin A1C from baseline to 24 weeks. The mean was -5.0 in the ranolazine group and 2.6 in the placebo group. The corresponding standard deviations were 6.2 and 9.1. The registry reports 9 participants in the ranolazine summary and 13 in the placebo summary. These values describe the recorded observations in each group; they are not a reported estimate of the difference between treatments.

The results do not establish the precision of a between-group comparison because the registry record does not report a comparative estimate, confidence interval, or p-value. They also do not show why the outcome summaries include fewer participants than the enrollment total. Without the analysis population and missing-data approach, it is not possible to determine how the posted results relate to every randomized participant.

In general, a biomarker result is not automatically equivalent to a change in symptoms, functioning, or other clinical outcomes. The registry’s stated purpose concerns cardiometabolic markers in women with stable angina, and the primary endpoint concerns hemoglobin A1C. The record does not report a clinical threshold for interpreting the observed percent changes or a connection between these summaries and patient-important outcomes. No conclusion about clinical benefit or harm follows from the arm means alone.

The safety record lists no serious adverse events and no deaths in either group, alongside 3 participants with other adverse events in the ranolazine group and none in the placebo group. These are counts, not proof that events were caused by or prevented by an assigned treatment. The small posted safety groups and lack of detail about event characteristics limit what can be inferred.

Overall, the registry supports a narrow description of the recorded outcome and safety summaries. It does not report the statistical comparison needed to quantify a treatment contrast, nor the methods needed to judge that contrast’s uncertainty. The information should not be stretched into a conclusion about whether ranolazine does or does not affect hemoglobin A1C or clinical outcomes.

14. Why This Trial Matters Statistically

This trial raises statistical questions that commonly arise when a randomized study reports arm-level summaries without a comparative analysis. Randomization can support a comparison between assigned groups, but interpreting that comparison requires an estimate of the contrast and information about its uncertainty. Here, the registry posts means and standard deviations for each group, while a two-arm comparison for the continuous endpoint is not available in the posted analyses.

The distinction between a group description and a treatment comparison is important. The means are useful for understanding the observed direction and scale of each group’s summary. They do not show how much uncertainty surrounds a difference between groups, whether an adjustment was used, or how missing endpoint data were handled. Statistical interpretation depends on those details, not solely on whether the group means have different signs.

The outcome counts also make analysis-population transparency relevant. Enrollment is listed as 33, while the primary endpoint summaries include 9 and 13 participants. The registry does not report why those counts differ. Without a participant flow or an explanation of missing observations, readers cannot determine how representative the outcome summaries are of the randomized groups.

Safety counts illustrate a related issue: event counts need context about definitions, duration, severity, and attribution. The record reports no serious adverse events and lists other adverse events in the ranolazine group, but does not provide event terms or a comparative safety analysis. In general, sparse counts are descriptive and do not by themselves establish the presence or absence of a difference.

The statistical value of the record is therefore in clarifying what was posted and what remains unreported. It identifies the endpoint, timeframe, arm summaries, and safety counts, while leaving important inferential and design details unavailable. Distinguishing those categories helps prevent an incomplete registry summary from being mistaken for a full statistical evaluation.

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 main trial-specific limitation is that the registry reports arm-level outcome summaries but not a two-arm comparison for the continuous primary endpoint. A comparative estimate, confidence interval, and p-value are not reported in the registry record. Consequently, the size and precision of a treatment contrast cannot be assessed from these results.

The primary outcome summaries include 9 participants in the ranolazine arm and 13 in the placebo arm, while enrollment is listed as 33. The reasons for the difference, participant flow, and missing-data handling are not reported in the registry record. The analysis population used for the means is also not reported, so the summaries cannot be assigned confidently to an intention-to-treat or other analysis approach.

The registry does not report baseline hemoglobin A1C summaries, participant characteristics, adherence, dose changes, or an adjusted analysis. Those omissions limit assessment of the context for the observed changes and of how the assigned regimens were implemented. The record also does not report a sample-size justification, the original target effect, or a statistical analysis plan. Its planning assumptions are described, but numerical planning estimates are not reported in the registry record.

The record lists 2 outcome measures but does not report secondary outcome results, a multiplicity strategy, or an analysis hierarchy. It does not explain the absence of a comparative analysis, beyond noting that values were missing or not estimable for a two-arm continuous-endpoint comparison. This leaves the analytic reason and any intended alternative method unclear.

For safety, the record gives affected counts and group sizes but does not report detailed event terms, timing, severity for other adverse events, or treatment attribution. The registry’s lack of detail limits interpretation of both outcome and safety data; it does not establish that unreported procedures or analyses were absent.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome — NCT02252406.
• Registry record last updated 2020-04-10; status last verified 2020-03.
• Results first posted 2020-04-10.
• 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.

19. Record Summary

The registry record describes a completed, randomized, quadruple-masked, parallel-group Phase 4 trial sponsored by the University of Florida. It lists enrollment of 33 and concerns women with stable angina and metabolic syndrome. Participants were assigned to ranolazine or matching placebo on top of standard medical therapy, with scheduled titration after 3 weeks.

The primary endpoint was mean percent change in hemoglobin A1C from baseline to 24 weeks. The ranolazine summary was -5.0, with a standard deviation of 6.2 among 9 participants; the placebo summary was 2.6, with a standard deviation of 9.1 among 13 participants. A comparative estimate and its uncertainty are not reported in the registry record.

The safety record lists no serious adverse events or deaths in either group and lists other adverse events in 3 ranolazine-group participants and 0 placebo-group participants. Reasons for the outcome counts, detailed analysis methods, and secondary outcome results are not reported in the registry record.