Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
1 other identifier
interventional
87
1 country
1
Brief Summary
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2007
Typical duration for phase_4
1 active site
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
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedOctober 19, 2010
July 1, 2007
1.6 years
October 18, 2010
October 18, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
One year
Secondary Outcomes (1)
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery
One Year
Study Arms (2)
Rosuvastatin 5mg/day
ACTIVE COMPARATORRosuvastatin 5mg/day
Rosuvastatin 40mg/day
ACTIVE COMPARATORRosuvastatin 40mg/day
Interventions
Eligibility Criteria
You may qualify if:
- STEMI
- no prior treatment with statins
You may not qualify if:
- 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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Odense University Hospital
Odense, Fuenen, 5000, Denmark
Related Publications (1)
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.
PMID: 21349594DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rasmus Egede, MD
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 19, 2010
Study Start
November 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2010
Last Updated
October 19, 2010
Record last verified: 2007-07