This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
SMART-DATE was a randomized, parallel-design treatment trial evaluating dual antiplatelet therapy duration after acute coronary syndromes.
| Feature | SMART-DATE |
|---|---|
| Condition | Acute Coronary Syndrome |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None |
| Primary purpose | Treatment |
| Lead sponsor | Samsung Medical Center |
| Intervention | P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) |
2. Clinical Question
Population
Patients with acute coronary syndrome enrolled in a randomized treatment trial.
Intervention
Dual antiplatelet therapy involving a P2Y12 inhibitor: clopidogrel, ticagrelor, or prasugrel.
Comparator
The registry identifies two randomized study arms evaluating treatment duration.
Primary question
The trial evaluated safety of 6-month duration of dual antiplatelet therapy after acute coronary syndromes.
3. Trial Design
Randomize
2712 patients
Treatment
Two arms
Follow-up
18 months
Endpoint
MACCE
4. Primary Endpoint
| Endpoint | Definition | Time Frame |
|---|---|---|
| MACCE | A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event | At 18-month after the index procedure |
5. Planned Analysis
The ClinicalTrials.gov record identifies the primary endpoint as a composite time-based clinical outcome. The registry does not report posted statistical analyses or outcome estimates for SMART-DATE.
For randomized trials with composite time-to-event endpoints, analyses commonly compare event occurrence between randomized groups using methods such as survival analysis approaches, including estimation of event rates over time and relative treatment effects. Interpretation requires attention to the components of the composite endpoint because individual components may contribute differently to the overall result.
6. Statistical Methodology
Composite endpoints
A composite endpoint combines multiple clinical outcomes into a single measure. This approach can increase statistical efficiency when individual events are related, but interpretation depends on whether the components have similar clinical importance and treatment effects.
Time-to-event analysis
The primary endpoint was defined over an 18-month period. Time-to-event methods account for differing follow-up durations and censoring when patients do not experience an event during observation.
Randomized treatment comparison
Randomization is intended to balance known and unknown prognostic factors between groups, allowing differences in outcomes to be attributed to the assigned intervention under the assumptions of the trial design.
7. Statistical Methods Explained
Why use a composite endpoint?
A composite endpoint can capture multiple clinically relevant outcomes while reducing the number of events needed for analysis. However, the contribution of each component must be considered when interpreting results.
What does an 18-month endpoint mean?
The registry defines the primary outcome assessment window as 18 months after the index procedure. It describes the period over which the endpoint is evaluated, not the duration of treatment effect beyond that period.
Why does randomization matter?
Random allocation helps create comparable groups before treatment begins. Statistical comparisons rely on this design feature to reduce confounding.
Why are composite outcomes statistically complex?
A composite outcome may be driven primarily by the most frequent component. A reduction in the overall composite does not automatically imply the same magnitude of effect for every component.
8. Limitations
- The ClinicalTrials.gov record does not report posted statistical analyses or numerical outcome estimates.
- The contribution of individual MACCE components cannot be evaluated from the registry information.
- Details of analysis populations, missing-data handling, multiplicity procedures, and interim analyses are not reported in the available registry record.
- Clinical interpretation of composite endpoints requires understanding the relative importance and frequency of each component.
9. Why This Trial Matters Statistically
| Concept | How it appears in SMART-DATE |
|---|---|
| Randomization | Randomized parallel treatment design |
| Composite endpoint | MACCE combining mortality, spontaneous MI, and cerebrovascular event |
| Time-to-event outcomes | Primary endpoint assessed at 18 months |
| Clinical trial methodology | Comparison of treatment strategies after acute coronary syndrome |
10. Sources
- ClinicalTrials.gov: SMART-DATE (NCT01701453)