An Observational Study of Statin Treatment Induced HDL Changes

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT01551784
• Lead Sponsor: AstraZeneca

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-14
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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