Clinical trial NCT01077830: 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)
Official title: A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: New Incidence of Cancer
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Institute of Applied Economics Aps, Denmark
First posted: 2010-03-01
Enrollment: 1392
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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).

Detailed description: The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050, MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial. The sources of study data will include data collected from national cancer and death registries as well as data from the original clinical trial. No patient visits will occur. National cancer and death registries exist in 5 of the 7 countries that participated in the base SEAS trial. At the time of Follow-up study initiation, accessing the registry data in Ireland was not feasible due to local regulations and Cancer and Death registries did not exist in Germany. As a result, data will be collected only for all SEAS patients known to be alive at the end of the base study originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.

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

Primary outcomes:
measure: Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort
timeFrame: up to 21 Months after the end of the SEAS (base) study
Secondary outcomes:
measure: Crude Rate of Death (Any Cause) - Follow-up Total Cohort
timeFrame: up to 21 Months after the end of the base study
measure: Crude Rate of Death Due to Cancer - Follow-up Primary Cohort
timeFrame: up to 21 Months after the end of the base study
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Green 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.