Clinical trial · Observational
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)
A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial
NCT01077830CI-TRIAL-00056412completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Ezetimibe/Simvastatin 10/40 mg
- description
- Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
- label
- Placebo
- description
- Participants who received placebo in the base study
Primary outcomes (1)
- measure
- Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort
- timeFrame
- up to 21 Months after the end of the SEAS (base) study
- description
- Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGreen A, Ramey DR, Emneus M, Iachina M, Stavem K, Bolin K, McNally R, Busch-Sorensen M, Willenheimer R, Egstrup K, Kesaniemi YA, Ray S, Basta N, Kent C, Pedersen TR. Incidence of cancer and mortality in patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. Am J Cardiol. 2014 Nov 15;114(10):1518-22. doi: 10.1016/j.amjcard.2014.08.016. Epub 2014 Aug 27. PMID 25267716