N/A
Completed N=1,359
An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)
Source: ClinicalTrials.gov NCT01077830 ↗Enrolled (actual)
1,359
Serious AEs
—
Results posted
Feb 2014
Primary outcomePrimary: Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort — 1.14; 2.07 per 100 participant-years
Summary
The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004\_050, MK0653A-043; NCT00092677).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort |
1.14; 2.07 | — |
| SECONDARY Crude Rate of Death (Any Cause) - Follow-up Total Cohort |
3.59; 2.70 | — |
| SECONDARY Crude Rate of Death Due to Cancer - Follow-up Primary Cohort |
0.38; 0.28 | — |
Eligibility Criteria
Inclusion Criteria
- The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study
Data sourced from ClinicalTrials.gov (NCT01077830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.