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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01551784
First received: March 5, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The health economic consequences of increasing HDL-C with statin treatment [ Time Frame: 1st of January 2004 to 31st December 2010 ] [ Designated as safety issue: No ]

Biospecimen Description:

Cholesterol values (HDL-C, LDL-C, TC)


Enrollment: 120000
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Detailed Description:

An observational study of statin treatment induced HDL changes - effect on cardiovascular disease

  Eligibility

Ages Eligible for Study:   18 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551784

Sponsors and Collaborators
AstraZeneca
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01551784     History of Changes
Other Study ID Numbers: NIS-CSE-CRE-2011/1
Study First Received: March 5, 2012
Last Updated: January 25, 2013
Health Authority: Sweden : National Board of Healt and Welfare

Keywords provided by AstraZeneca:
Statin treatment
Cardiovascular disease
Statin treatment induced HDL changes and the effect on cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013