Endothelial DysfunctionPhase 4NCT01223625
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
A Phase 4 study testing Rosuvastatin 5mg/day and Rosuvastatin 40mg/day in people with Endothelial Dysfunction and Atherosclerosis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Endothelial Dysfunction, Atherosclerosis
- What is being tested?
- Rosuvastatin 5mg/day and Rosuvastatin 40mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Jun 2010
- Phase
- Phase 4
- 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 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI
- no prior treatment with statins
Who cannot join
- age below 18 or above 81 years
- unconscious patients
- serum creatinine > 176μmol/L
- total-cholesterol > 7.0 mmol/l
- hypothyreoidism ((TSH > 1.5 x ULN (upper limit of normal))
- current liver disease (ALAT > 2 x ULN)
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- unexplained creatine kinase > 3 x ULN
- alcohol or drug abuse within the last five years
- prior myopathy or serious hypersensitivity reaction caused by statins
- women with childbearing potential who were not using chemical or mechanical contraception
- pregnant or breastfeeding women
- history of malignancy unless a disease-free period of more than five years was present
- patients with abnormal lung function test (LFT)
- participation in another investigational drug study less than four weeks before enrolment in the present study
- treatment with cyclosporine or fibrates.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Odense University Hospital
Odense, Fuenen, 5000
About this study
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.
- Conditions
- Endothelial Dysfunction, Atherosclerosis
- Being tested
- Rosuvastatin 5mg/day, Rosuvastatin 40mg/day
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 5mg/dayDrug
Also called Crestor
Rosuvastatin 5mg/day
Rosuvastatin 40mg/dayDrug
Also called Crestor
Rosuvastatin 40mg/day
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 5mg/day | Active comparator | Rosuvastatin 5mg/day Receives: Drug: Rosuvastatin 5mg/day |
| Rosuvastatin 40mg/day | Active comparator | Rosuvastatin 40mg/day Receives: Drug: Rosuvastatin 40mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
Measured: One year
Secondary outcomes (1)
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Rasmus Egede, MD, Principal investigator, Department of Cardiology, Odense University Hospital, Odense, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223625
- Sponsor's protocol ID
- VF-200600
- Status last verified
- Jul 2007
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Egede R, Jensen LO, Hansen HS, Antonsen L, Hansen KN, Junker A, Thayssen P. Effect of intensive lipid-lowering treatment compared to moderate lipid-lowering treatment with rosuvastatin on endothelial function in high risk patients. Int J Cardiol. 2012 Jul 26;158(3):376-9. doi: 10.1016/j.ijcard.2011.01.071. Epub 2011 Feb 23.
PubMed 21349594
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
- ClinicalTrials.gov ID
- NCT01223625
- Acronym / sponsor ID
- VF-200600
- Conditions
- Endothelial Dysfunction, Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Oct 2010 (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 of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 5mg/day | Active comparator | Drug: Rosuvastatin 5mg/dayRosuvastatin 5mg/day |
| Rosuvastatin 40mg/day | Active comparator | Drug: Rosuvastatin 40mg/dayRosuvastatin 40mg/day |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- STEMI
- no prior treatment with statins
Key exclusion criteria (15 listed)
- age below 18 or above 81 years
- unconscious patients
- serum creatinine > 176μmol/L
- total-cholesterol > 7.0 mmol/l
- hypothyreoidism ((TSH > 1.5 x ULN (upper limit of normal))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 5mg/dayAlso: CrestorRosuvastatin 5mg/day | Drug | Rosuvastatin 5mg/day |
| Rosuvastatin 40mg/dayAlso: CrestorRosuvastatin 40mg/day | Drug | Rosuvastatin 40mg/day |
Primary outcome
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
Time frame: One year
1 secondary outcome
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery
Time frame: One Year
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 19 Oct 2010.
- Derived from this study: PubMed 21349594Egede R, Jensen LO, Hansen HS, Antonsen L, Hansen KN, Junker A, Thayssen P. Effect of intensive lipid-lowering treatment compared to moderate lipid-lowering treatment with rosuvastatin on endothelial function in high risk patients. Int J Cardiol. 2012 Jul 26;158(3):376-9. doi: 10.1016/j.ijcard.2011.01.071. Epub 2011 Feb 23.
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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.
Rasmus Egede, MD principal investigator
Department of Cardiology, Odense University Hospital, Odense, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 5mg/day and Rosuvastatin 40mg/day in people with Endothelial Dysfunction and Atherosclerosis, run by Odense University Hospital at 1 site in Denmark.
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 15 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 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223625, which also lists 1 linked publication.
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 19 Oct 2010.