NCT01551784|Completed
An Observational Study of Statin Treatment Induced HDL Changes
SIRIUS
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SIRIUS
Sponsor study identifier
observational
120,000
0 countries
N/A
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 5, 2012
Actual (reported)March 13, 2012
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)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
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
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.
Cholesterol values (HDL-C, LDL-C, TC)
Gunnar Johansson, MD, PROFESSOR
Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Uppsala University 751 22 Uppsala Sweden
Ron Herings, DR, ASSOC PROF
Pharmo Institute for Drug Outcomes Research3508 AE UtrechtThe Netherlands
120,000 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2012
First Posted
March 13, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
PLATELET TISSUE FACTOR AS BIOMARKER OF THROMBOTIC RISK IN CORONARY ARTERY DISEASE PATIENTS (TRIT-ONE)
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
October 16, 2013
Record last verified: 2013-10
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Source: ClinicalTrials.gov.
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