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)

• ClinicalTrials.gov Identifier: NCT01077830
• Recruitment Status: Completed
• First Posted: March 1, 2010
• Results First Posted: February 4, 2014
• Last Update Posted: November 1, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Institute of Applied Economics Aps, Denmark
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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).

Condition or disease
Cancer

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1392 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial
• Study Start Date: March 2010
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: April 2013

Groups and Cohorts

Group/Cohort
Ezetimibe/Simvastatin 10/40 mg; Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
Placebo; Participants who received placebo in the base study

Outcome Measures

Primary Outcome Measures :

1. Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort [ Time Frame: up to 21 Months after the end of the SEAS (base) study ]
   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 Outcome Measures :

1. Crude Rate of Death (Any Cause) - Follow-up Total Cohort [ Time Frame: up to 21 Months after the end of the base study ]
   All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death 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 Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.
2. Crude Rate of Death Due to Cancer - Follow-up Primary Cohort [ Time Frame: up to 21 Months after the end of the base study ]
   All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer 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 Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Institute of Applied Economics Aps, Denmark

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Additional Information:

Current view of trial on ClinicalTrials.gov 

Publications of Results:

Green A, Ramey DR, Emneus M, Iachina M, Stavem K, Bolin K, McNally R, Busch-Sørensen M, Willenheimer R, Egstrup K, Kesäniemi 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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT01077830
• Other Study ID Numbers: 0653A-043-10; 2010_016 ( Other Identifier: Merck Registration Number )
• First Posted: March 1, 2010
• Results First Posted: February 4, 2014
• Last Update Posted: November 1, 2015
• Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:

New Incidence of Cancer