An Observational Study of Statin Treatment Induced HDL Changes
SIRIUS
1 other identifier
observational
120,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 16, 2013
October 1, 2013
7 months
March 5, 2012
October 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (1)
1
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Malignancy Alcohol abuse/alcohol dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Biospecimen
Cholesterol values (HDL-C, LDL-C, TC)
MeSH Terms
Conditions
Study Officials
- 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
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 13, 2012
Study Start
March 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 16, 2013
Record last verified: 2013-10