Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial (NCT00991029), a randomized phase 3 study. The primary outcome is Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes.

2. Clinical Question

The POINT trial focused on a composite of ischemic vascular events after TIA or minor ischemic stroke. The registry describes TIA as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia without acute infarction, and ischemic stroke as a cerebral infarction. Its stated eligibility is narrower than all transient neurological events: it specifies brain TIAs and minor ischemic strokes.

The primary outcome combines three event types into a single measure. That approach addresses whether participants experienced any of the specified events during follow-up, rather than treating each component as the sole primary question. It also means the combined result should be interpreted as a result for this particular composite; it does not establish that every component followed the same pattern. Component outcomes are listed separately in the posted results.

The comparison is between assigned treatment strategies, each of which included aspirin. The contrast is therefore clopidogrel added to aspirin versus placebo added to aspirin, not clopidogrel versus no treatment. The registry record identifies a randomized, double-masked, parallel trial. Details of the randomization procedure, adherence, and the primary analysis population are not reported in the registry record.

3. Trial Design

POINT is a phase 3, randomized, double-masked, parallel-group trial sponsored by the University of California, San Francisco. The registry reports enrollment of 4881 participants. The listed start date is 2010-05-28, and the primary completion date is 2018-04-09. The current registry status is terminated; the reason for termination is not reported in the registry record.

Participants were assigned to clopidogrel or placebo, with aspirin included in both arm descriptions. The clopidogrel group included 2432 participants in the posted primary outcome results, and the placebo group included 2449. The registry’s brief summary describes eligibility as brain TIA or minor ischemic stroke, with an NIH Stroke Scale score less than or equal to 3 for minor stroke. Further eligibility criteria and the method used to generate or conceal assignments are not reported in the registry record.

The primary outcome is the count of participants with ischemic stroke, myocardial infarction, or death from ischemic vascular causes, assessed up to 90 days. The posted primary outcome is presented as participant counts by group, while the sponsor’s reported comparison uses a log-rank method and a hazard ratio. These are different ways of summarizing the group comparison: one describes the recorded event counts, and the other incorporates event timing.

The registry also lists secondary outcomes, including the individual components of the primary composite and other stroke or hemorrhage measures. The posted results include secondary analyses for ischemic stroke, myocardial infarction, and death from ischemic vascular causes. The original protocol, the detailed statistical analysis plan, and the basis for the trial’s planned enrollment 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.

Overall Study

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 Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes, measured over Up to 90 days.

The primary endpoint counts participants who experienced ischemic stroke, myocardial infarction, or death from ischemic vascular causes up to 90 days. It is a composite endpoint: a participant can contribute to the outcome by experiencing any of the specified event types. The registry reports the number of participants with an event in each group, rather than a continuous measurement.

In general, a composite can summarize several clinically relevant event types in one primary measure. It can also provide a broader view of events than any single component alone. Interpretation depends on the components: they may differ in frequency and seriousness, and a composite result does not show by itself whether the observed group pattern is consistent across all components. The individual component results therefore add useful context, while remaining secondary analyses in this record.

For this trial, the endpoint focuses on ischemic vascular events after brain TIA or minor ischemic stroke. The posted timeframe is up to 90 days. The registry does not report a more detailed definition of each event, how events were independently reviewed or confirmed, or how multiple events in the same participant were handled for the primary count. Those details are not reported in the registry record.

7. Results Posted in the Registry

• Clopidogrel: 5.0% (121/2432) versus 6.5% (160/2449) on control; risk difference -1.6 percentage points (95% CI -2.9 to -0.3), risk ratio 0.76 (0.61–0.96); unadjusted two-proportion z-test p = 0.019.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Ischemic Stroke

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Clopidogrel: 4.6% (112/2432) versus 6.3% (155/2449) on control; risk difference -1.7 percentage points (95% CI -3.0 to -0.4), risk ratio 0.73 (0.57–0.92); unadjusted two-proportion z-test p = 0.008.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Clopidogrel than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Myocardial Infarction

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Clopidogrel: 0.4% (10/2432) versus 0.3% (7/2449) on control; risk difference 0.1 percentage points (95% CI -0.2 to 0.5), risk ratio 1.44 (0.55–3.77); unadjusted two-proportion z-test p = 0.457.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Clopidogrel and the control. The interval gives the range of effects that remain compatible with the data.

Death From Ischemic Vascular Causes

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Clopidogrel: 0.2% (6/2432) versus 0.2% (4/2449) on control; risk difference 0.1 percentage points (95% CI -0.2 to 0.3), risk ratio 1.51 (0.43–5.35); unadjusted two-proportion z-test p = 0.519.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Clopidogrel and the control. The interval gives the range of effects that remain compatible with the data.

The available secondary results show a pattern that is not uniform across all components. The ischemic stroke comparison points in the same direction as the primary composite. By contrast, the point estimates for myocardial infarction and death from ischemic vascular causes point in the opposite direction, but their confidence intervals are broad and include the no-relative-difference value. The outcome tables present the individual counts and estimates; this overview focuses on the pattern across them.

That pattern does not overturn or independently confirm the composite result. The primary endpoint combines ischemic stroke, myocardial infarction, and death from ischemic vascular causes, while the component analyses separate those outcomes. A composite can be driven more by some components than others, and component estimates can be less precise when events are sparse. The registry does not report a component-weighting scheme or additional interpretation that would resolve those differences.

Secondary comparisons generally carry less evidential weight than a prespecified primary comparison, especially when many outcomes are examined. Repeated testing can increase the chance of a seemingly notable result occurring by chance. The registry does not report a multiplicity adjustment, a testing hierarchy, or which secondary analyses were designated confirmatory. Their p-values should therefore be treated as unadjusted evidence, not as stand-alone proof.

The registry lists other secondary outcomes, including stroke measures and a composite that includes major hemorrhage, but detailed arm-level results for all listed outcomes are not reported in the registry record. Conclusions about those unshown outcomes cannot be drawn from the analyses.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Ischemic Stroke
• Myocardial Infarction
• Death From Ischemic Vascular Causes
• Ischemic or Hemorrhagic Stroke
• Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage

9. Statistical Interpretation

10. Statistical Methods Explained

The primary posted outcome is binary at the participant level: each participant is classified according to whether the specified composite event was recorded. The registry reports event counts and group sizes. A risk is the proportion of participants in a group who experienced the outcome; the posted risk estimates are 0.050 for clopidogrel and 0.065 for placebo. The reported risk difference is the clopidogrel risk minus the placebo risk, estimated as -0.016.

As a general statistical explanation, a risk difference describes an absolute contrast between groups on the risk scale. A negative value means the estimated risk is lower in the clopidogrel group under the stated subtraction order. It is not a hazard ratio, and it does not directly describe the timing of events. Its confidence interval, from -0.029 to -0.003, conveys the range of values reasonably compatible with the estimate under the method used to calculate it. The specific confidence-interval procedure for this recalculation is not reported in the registry record.

The registry also posts relative measures in the recalculated comparison: a risk ratio of 0.761 with a 95% confidence interval from 0.606 to 0.958, and an odds ratio of 0.749 with a 95% confidence interval from 0.587 to 0.955. In general, a risk ratio compares risks, while an odds ratio compares odds. Both are relative measures and answer a different descriptive question from the absolute risk difference. They should not be treated as interchangeable, particularly when explaining an absolute change in event probability.

The sponsor’s primary comparison uses a log-rank method and reports a hazard ratio of 0.75, a 95% confidence interval from 0.59 to 0.95, and p = 0.02. In general, log-rank methods compare time-to-event experience between groups while accounting for when events occur. A hazard ratio summarizes the relative event hazard over follow-up, subject to the model and assumptions used. The registry does not report the details needed to assess those assumptions, such as the handling of censoring or whether proportional hazards were evaluated.

The sponsor’s time-to-event result and the count-based recalculation are not competing estimates of exactly the same quantity. The recalculation uses posted summary counts and gives an unadjusted risk difference and related binary comparisons. The sponsor’s log-rank analysis uses event timing and reports a hazard ratio. Because the registry does not flag a discrepancy, the available results are directionally aligned; differences in their numerical values are expected because the measures and methods differ. The registry does not report covariate adjustment for the sponsor’s primary comparison.

A p-value measures how unusual data at least as incompatible with a specified null hypothesis would be under that hypothesis and the analysis assumptions. It is not the probability that the null hypothesis is true, nor does it describe the size or clinical importance of an effect. The recalculated unadjusted p-value is 0.019; the sponsor’s reported p-value is 0.02. The distinct values reflect the distinct analyses and reporting precision, not a reason to substitute one for the other.

Confidence intervals are central to interpretation because they show uncertainty around an estimate, not just whether a threshold is crossed. For a risk difference, zero is the no-difference value. For a ratio measure such as a hazard ratio, risk ratio, or odds ratio, 1 is the no-relative-difference value. In general, a wider interval indicates less precision, and an interval spanning the relevant null value leaves a range of possibilities that includes no difference under that measure.

The posted secondary analyses use the same general kinds of outcomes, and the registry reports sponsor log-rank analyses for ischemic stroke, myocardial infarction, and death from ischemic vascular causes. Their estimates and intervals are shown with the outcome tables. Those component results are not equivalent to a separately powered primary test, and the registry does not report a procedure for controlling the chance of false-positive findings across multiple secondary comparisons.

These explanations describe general statistical concepts and the methods identified in the registry. The detailed statistical analysis plan, rules for censoring and missing data, and analysis population definitions are not reported in the registry record. Without those details, the posted results can be described, but a full audit of the analysis cannot be reconstructed from the record alone.

11. Confidence Intervals and Precision

The primary risk difference is -0.016, with a 95% confidence interval from -0.029 to -0.003. The interval is entirely below zero, the no-difference value for a risk difference. This indicates that the posted estimate is more precise about direction than an interval that crossed zero would be, while still leaving uncertainty about the magnitude of the difference.

The sponsor’s hazard ratio is 0.75, with a 95% confidence interval from 0.59 to 0.95. For a hazard ratio, 1 is the no-relative-difference value. The interval lies below 1, but it spans a range of relative effects rather than identifying one exact value. Its interpretation is specific to the sponsor’s time-to-event analysis and should not be transferred directly to the risk-difference scale.

Precision varies across the secondary outcomes. The ischemic stroke confidence interval is from 0.56 to 0.92 for the sponsor’s hazard ratio. For myocardial infarction, it is from 0.55 to 3.78, and for death from ischemic vascular causes, it is from 0.43 to 5.35. The latter intervals are broad and include 1, so those estimates are compatible with a wide range of relative effects, including no relative difference. This uncertainty is important when interpreting outcomes with comparatively few recorded events.

In general, a confidence interval is not a guarantee that the true effect lies within its limits. It is a measure of uncertainty under the method and assumptions used to construct it. The registry does not report all calculation details, and the posted estimates should be read with that limitation in mind.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size section is a planning illustration based on the observed effect, not a description of the trial’s original design assumptions. For binary outcomes such as the primary endpoint, the displayed figures are participants per arm. For time-to-event planning tables, the figures are total events, using the Schoenfeld approach. This primary outcome is a participant-count outcome, so its planning figures are per arm.

The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The planning table displays scenarios using 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. The original trial’s sample-size assumptions and justification are not reported in the registry record.

In plain language, the 80% power column gives the participants per arm estimated to yield an 80% chance of detecting the selected effect under the stated assumptions if that effect were the true one. The 90% power column gives the corresponding planning figure for a 90% chance. These are design calculations, not guarantees about a particular study’s result. Smaller effects are harder to detect and therefore require more participants under the same assumptions.

The displayed curve and table should be read as planning aids: they show how the required group size changes when the target effect or desired power changes. They do not tell us the probability that the completed trial’s result is correct, and this is not observed power. The illustration uses the observed effect as its reference, so it should not be mistaken for the trial’s prospective sample-size calculation.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.065; treatment proportion p₁ = 0.050; average p̄ = 0.058.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.3293 = 0.6455.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.3292 = 0.2770.
4. n = (0.6455 + 0.2770)² / (-0.0156)² = 3,506.2, rounded up to 3,507 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.0653327888934259                          # control proportion
p1 <- 0.0497532894736842                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(991029)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 3,507 (80% power), 4,694 (90% power)
 75% of observed effect: n per arm = 6,432 (80% power), 8,610 (90% power)
 50% of observed effect: n per arm = 14,917 (80% power), 19,968 (90% power)
power.prop.test: 3506.2 
Simulated power at n = 3,507 per arm: 0.811 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor’s primary analysis is a log-rank comparison reported as a hazard ratio of 0.75, with a 95% confidence interval from 0.59 to 0.95 and p = 0.02. It uses event-time information. The recalculation shown alongside it is based on the posted participant counts and gives a risk difference of -0.016, with a 95% confidence interval from -0.029 to -0.003 and an unadjusted p-value of 0.019.

These estimates address the same broad primary comparison but express it on different scales and use different methods. The risk difference describes the contrast in participant-level event risk based on the posted counts. The hazard ratio summarizes relative event hazard over time using the sponsor’s log-rank analysis. A numerical match is not expected. Both estimates point in the same direction in the posted results, and the registry record does not indicate a discrepancy. The sponsor’s own analysis remains the reported trial analysis; the recalculation is a supplementary, unadjusted summary rather than a replacement.

The registry does not report enough detail to reproduce the sponsor’s full time-to-event analysis, including the detailed analysis population and handling of censoring. The recalculation likewise cannot add adjustment or information that is absent from the posted summary counts. Readers should therefore distinguish the sponsor-reported result from the simple recalculation and consider what each method summarizes.

15. Multiplicity, Missing Data and Analysis Populations

The registry record does not report whether the trial used a prespecified multiplicity strategy for the primary and secondary outcomes. It does not describe a hierarchical testing plan, an adjustment to significance thresholds, or another method to account for the number of comparisons. This matters because examining multiple outcomes can increase the chance of at least one apparently strong result even when no corresponding effect exists. The secondary results should therefore be read as exploratory or supportive unless a prespecified confirmatory role is documented elsewhere; that role is not reported in the registry record.

The record also does not report how missing outcome data were handled, whether follow-up differed between groups, or how participants who stopped assigned treatment were analyzed. The posted group sizes and outcome counts are available, but they do not by themselves establish whether every randomized participant had complete outcome ascertainment or how any incomplete records were treated. The analysis population, such as whether the primary analysis followed assignment regardless of treatment received, is not reported in the registry record.

Interim analyses and any associated stopping boundaries are not reported in the registry record. Neither the original statistical analysis plan nor a detailed account of prespecified covariate adjustment is reported. The registry status is terminated, but the reason for termination and whether it was related to the results or another operational issue are not reported in the registry record. It would be inappropriate to infer these details from the status alone.

These gaps limit how fully the posted analyses can be evaluated. They do not change the numbers shown in the results tables, but they prevent a complete assessment of whether all decisions were prespecified and how missingness or repeated testing may affect inference. Readers should distinguish what the registry reports from details that would require the protocol, analysis plan, or a fuller results report.

16. 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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: ischaemic stroke (4.6%), transient ischaemic attack (2.2%), atrial fibrillation (1.0%), cerebrovascular accident (0.9%), carotid artery stenosis (0.7%).

The registry’s adverse-event summary lists serious adverse events affecting 382 participants in the clopidogrel group and 382 in the placebo group. It lists 2432 participants at risk in the clopidogrel group and 2449 in the placebo group. Other adverse events are recorded for 89 and 84 participants, respectively, and deaths are recorded as 18 and 12. These are the posted counts; the registry summary does not explain the event definitions or provide a comparative statistical analysis for these figures.

The most frequently listed serious adverse-event terms include ischaemic stroke at 4.6%, transient ischaemic attack at 2.2%, atrial fibrillation at 1.0%, cerebrovascular accident at 0.9%, carotid artery stenosis at 0.7%, and chest pain at 0.5%. The registry presents these terms and percentages, but does not specify whether the percentages are pooled across groups or provide group-specific breakdowns. They should not be interpreted as a comparison between treatment arms.

The adverse-event death counts are not necessarily the same measure as the primary endpoint component, which is death from ischemic vascular causes. The registry does not provide enough detail to equate those categories. These summaries describe recorded events; they do not alone establish a causal relationship to assigned treatment or support a complete comparative safety assessment.

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

The posted primary results show fewer recorded participants with the composite outcome in the clopidogrel group than in the placebo group, with the count-based estimate and sponsor’s time-to-event estimate both pointing in that direction. The confidence intervals communicate uncertainty around each estimate, and the measures are not interchangeable. The finding applies to the trial’s specified composite, population, treatment comparison, and follow-up of up to 90 days.

It does not show that every component of the composite changed in the same direction. The secondary component analyses differ in direction and precision, and some have wide intervals that include the no-difference value. Nor does the result identify which component contributed most to the composite pattern based solely on the overall estimate.

The registry record does not provide the full protocol or detailed statistical analysis plan, the primary analysis population, missing-data procedures, interim-analysis details, or a multiplicity strategy. Those omissions limit assessment of the full inferential context. The registry status of terminated does not reveal why the trial ended, and the reason is not reported in the registry record.

These results are statistical descriptions of the posted trial data, not individualized predictions. They do not establish what would happen for a particular person or in populations outside the eligibility described in the record. They also do not, by themselves, settle questions about clinical importance, long-term outcomes, or the balance of benefits and harms. Such conclusions require information beyond the posted estimates and should not be inferred from a p-value or confidence interval alone.

18. Why This Trial Matters Statistically

POINT illustrates why the endpoint and effect measure matter in clinical trial interpretation. The primary endpoint is a composite of ischemic stroke, myocardial infarction, and death from ischemic vascular causes. The posted count-based comparison describes an absolute risk difference, while the sponsor’s log-rank analysis describes a time-to-event hazard ratio. Both are useful summaries, but they answer different statistical questions and should be read on their own scales.

The trial also shows why a composite result should be considered alongside its components. A combined endpoint can produce a clearer overall summary, but it can conceal variation among the individual outcomes. Here the secondary estimates do not all point in the same direction, and their intervals differ in precision. The component results help readers see that the primary composite should not be translated into a claim about every event type.

Finally, the record demonstrates the value of separating reported analyses from recalculations and planning illustrations. The sponsor’s analysis uses event timing; a simple recalculation from posted counts provides a transparent but narrower comparison. The sample-size section illustrates how planning needs change with target effect size and desired power, but it is not evidence of the trial’s original design assumptions or its probability of success. These distinctions support a careful reading of clinical trial evidence without overstating what the registry record can establish.

19. 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.

Several limitations are specific to what is available for this trial in the registry record. The brief summary gives a broad eligibility description, but detailed inclusion and exclusion criteria are not reported. The randomization procedure, allocation concealment, treatment adherence, and follow-up procedures are also not reported. The record states that the trial was double-masked, but does not give further detail about which roles were masked or how masking was maintained.

The primary outcome is posted as participant counts, and the sponsor reports a time-to-event analysis. Detailed endpoint adjudication procedures, censoring rules, and the handling of recurrent events are not reported in the registry record. The detailed analysis population and missing-data approach are likewise not reported, limiting assessment of whether the posted estimates represent all randomized participants and how incomplete follow-up may have been addressed.

The registry does not report the trial’s original sample-size justification, full statistical analysis plan, interim analyses, or multiplicity procedures. The status is terminated, but the reason is not reported. The safety summary provides counts and common serious adverse-event terms, without a full comparative analysis or enough detail to attribute those events to assigned treatment.

These are limits of the available record, not evidence that the trial did or did not follow a particular procedure. Additional trial documentation could clarify them, but it is not part of the registry information.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial — NCT00991029.
• Registry record last updated 2018-12-04; status last verified 2018-11.
• Results first posted 2018-12-04.
• 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.

23. Record Summary

POINT is a phase 3, randomized, double-masked, parallel-group trial sponsored by the University of California, San Francisco. The registry reports enrollment of 4881 participants and lists the status as terminated. Participants were assigned to clopidogrel plus aspirin or placebo plus aspirin. The registry describes eligibility as brain TIA or minor ischemic stroke, with an NIH Stroke Scale score less than or equal to 3 for minor stroke.

The primary endpoint counts participants with ischemic stroke, myocardial infarction, or death from ischemic vascular causes up to 90 days. The posted counts are 121 of 2432 in the clopidogrel group and 160 of 2449 in the placebo group. The sponsor reports a log-rank hazard ratio of 0.75, with a 95% confidence interval from 0.59 to 0.95 and p = 0.02. The registry does not report the detailed analysis plan, missing-data methods, or reason for termination.