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An Observational Study of Statin Treatment Induced HDL Changes (SIRIUS)

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ClinicalTrials.gov Identifier: NCT01551784
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date March 5, 2012
First Posted Date March 13, 2012
Last Update Posted Date October 16, 2013
Study Start Date March 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 9, 2012)
Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C [ Time Frame: 1st of January 2004 to 31st December 2010 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01551784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 9, 2012)
  • The effect of statin induced changes in HDL-C (per mmol/L) on a composite endpoint including unstable angina pectoris, myocardial infarction, ischemic stroke and all cause mortality. [ Time Frame: 1st of January 2004 to 31st December 2010 ]
  • Time to first occurence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke and ischemic heart disease mortality related to changes in HDL-C. [ Time Frame: 1st of January 2004 to 31st December 2010 ]
  • The relationships between acquired HDL levels after statin treatment on the primary endpoint and the effect of HDL increase on the primary endpoint for different levels of baseline HDL [ Time Frame: 1st of January 2004 to 31st December 2010 ]
  • Potential interactions between baseline HDL and HDL increase and other factors like age, gender, treatment and co-morbidity on the primary endpoint [ Time Frame: 1st of January 2004 to 31st December 2010 ]
  • The health economic consequences of increasing HDL-C with statin treatment [ Time Frame: 1st of January 2004 to 31st December 2010 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Statin Treatment Induced HDL Changes
Official Title An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease
Brief Summary The aim with this study is to investigate the effect of statin induced changes in HDL-C on all cause mortality and CVD with adjustment for changes in other blood lipids and clinical parameters in Sweden, UK and the Netherlands.
Detailed Description An observational study of statin treatment induced HDL changes - effect on cardiovascular disease
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Cholesterol values (HDL-C, LDL-C, TC)
Sampling Method Non-Probability Sample
Study Population Patients who received a first prescription of a statin (ATC code C10AA) between 1st of January 2004 and 31st of December 2010. Swedish data will be extracted from medical records and national registers and for UK and the Netherlands from central registers.
Condition Cardiovascular Disease
Intervention Not Provided
Study Groups/Cohorts 1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 9, 2012)
120000
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Started treatment with statins within the observation period (2004-2010)
  • The patient must have valid baseline and follow-up measurements for HDL-C and LDL-C.

Exclusion Criteria:

  • Malignancy Alcohol abuse/alcohol dependence
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 86 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01551784
Other Study ID Numbers NIS-CSE-CRE-2011/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Principal Investigator: Gunnar Johansson, MD, PROFESSOR Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Uppsala University 751 22 Uppsala Sweden
Principal Investigator: Ron Herings, DR, ASSOC PROF Pharmo Institute for Drug Outcomes Research3508 AE UtrechtThe Netherlands
PRS Account AstraZeneca
Verification Date October 2013