Comparison · NCT02596126-sae
Treatment Prevention for Secondary CV vs Cardiovascular Polypill: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Treatment Prevention for Secondary CV vs Cardiovascular Polypill: serious adverse events. Trial comparisons, record NCT02596126-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02596126-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.179 | 0.159 | 0.201 | wilson | |
| Risk in group 2 | 0.2 | 0.179 | 0.224 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0215 | -0.0524 | 0.0095 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.893 | 0.758 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.87 | 0.711 | 1.06 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment Prevention for Secondary CV than on Cardiovascular Polypill | 46.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment Prevention for Secondary CV | Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians..~Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention. | 220 | 1,229 | EG000 |
| Group 2 | Cardiovascular Polypill | Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.~Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril.~Participants will receive one of the following cardiovascular polypill:~(A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).~or~(B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). | 248 | 1,237 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5 Years.
Source ClinicalTrials.gov
Trial
- Title
- Secondary Prevention of Cardiovascular Disease in the Elderly Trial
- NCT number
- NCT02596126
- Phases
- PHASE3
- Conditions
- Myocardial Infarction, Cardiovascular Disease
- Interventions
- Cardiovascular Polypill, Treatment Prevention for Secondary CV
- Lead sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Results first posted
- 2025-05-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02596126?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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