Cardiovascular DiseaseSIRIUSNCT01551784
An Observational Study of Statin Treatment Induced HDL Changes
An observational study of Cardiovascular Disease, run by AstraZeneca.
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. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 120,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Malignancy Alcohol abuse/alcohol dependence
About this study
Official title: An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease
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.
Read the detailed description
An observational study of statin treatment induced HDL changes - effect on cardiovascular disease
- Conditions
- Cardiovascular Disease
- Keywords
- Statin treatment, Cardiovascular disease, Statin treatment induced HDL changes and the effect on cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1st of January 2004 to 31st December 2010
The health economic consequences of increasing HDL-C with statin treatment
Measured: 1st of January 2004 to 31st December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 120,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Johansson, MD, PROFESSOR, Principal investigator, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Uppsala University 751 22 Uppsala SwedenRon Herings, DR, ASSOC PROF, Principal investigator, Pharmo Institute for Drug Outcomes Research3508 AE UtrechtThe Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551784
- Sponsor's protocol ID
- NIS-CSE-CRE-2011/1
- Acronym
- SIRIUS
- Status last verified
- Oct 2013
- First submitted
- 5 Mar 2012
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01551784
- Acronym / sponsor ID
- SIRIUS / NIS-CSE-CRE-2011/1
- Conditions
- Cardiovascular Disease
- Keywords
- Statin treatment, Cardiovascular disease, Statin treatment induced HDL changes and the effect on cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Malignancy Alcohol abuse/alcohol dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C
Time frame: 1st of January 2004 to 31st December 2010
5 secondary outcomes
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 1st of January 2004 to 31st December 2010
The health economic consequences of increasing HDL-C with statin treatment
Time frame: 1st of January 2004 to 31st December 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Johansson, MD, PROFESSOR principal investigator
Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Uppsala University 751 22 Uppsala Sweden
Ron Herings, DR, ASSOC PROF principal investigator
Pharmo Institute for Drug Outcomes Research3508 AE UtrechtThe Netherlands
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C (time frame: 1st of January 2004 to 31st December 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.