An Observational Study of Statin Treatment Induced HDL Changes

Cardiovascular Disease Clinical Trial

— SIRIUS  

Official title:

An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551784
• Other study ID #: NIS-CSE-CRE-2011/1
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: October 14, 2013
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden : National Board of Healt and Welfare
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120000
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 86 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C		1st of January 2004 to 31st December 2010	No
Secondary	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.		1st of January 2004 to 31st December 2010	No
Secondary	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.		1st of January 2004 to 31st December 2010	No
Secondary	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		1st of January 2004 to 31st December 2010	No
Secondary	Potential interactions between baseline HDL and HDL increase and other factors like age, gender, treatment and co-morbidity on the primary endpoint		1st of January 2004 to 31st December 2010	No
Secondary	The health economic consequences of increasing HDL-C with statin treatment		1st of January 2004 to 31st December 2010	No