An Observational Study of Statin Treatment Induced HDL Changes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01551784

Acronym

SIRIUS

Enrollment

120000

Registered

2012-03-13

Start date

2012-03-31

Completion date

2012-10-31

Last updated

2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Statin treatment, Cardiovascular disease, Statin treatment induced HDL changes and the 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

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 86 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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
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
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
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
The health economic consequences of increasing HDL-C with statin treatment	1st of January 2004 to 31st December 2010

Outcome results