Back to resultsEffect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
Primary Purpose
Endothelial Dysfunction, Atherosclerosis
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Rosuvastatin 5mg/day
Rosuvastatin 40mg/day
Sponsored by
About this trial
This is an interventional treatment trial for Endothelial Dysfunction
Eligibility Criteria
Inclusion Criteria:
- STEMI
- no prior treatment with statins
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Cardiology, Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rosuvastatin 5mg/day
Rosuvastatin 40mg/day
Arm Description
Rosuvastatin 5mg/day
Rosuvastatin 40mg/day
Outcomes
Primary Outcome Measures
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
Secondary Outcome Measures
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery
Full Information
NCT ID
NCT01223625
First Posted
October 18, 2010
Last Updated
October 18, 2010
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01223625
Brief Title
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
Official Title
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin 5mg/day
Arm Type
Active Comparator
Arm Description
Rosuvastatin 5mg/day
Arm Title
Rosuvastatin 40mg/day
Arm Type
Active Comparator
Arm Description
Rosuvastatin 40mg/day
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 5mg/day
Other Intervention Name(s)
Crestor
Intervention Description
Rosuvastatin 5mg/day
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 40mg/day
Other Intervention Name(s)
Crestor
Intervention Description
Rosuvastatin 40mg/day
Primary Outcome Measure Information:
Title
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
Time Frame
One year
Secondary Outcome Measure Information:
Title
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
STEMI
no prior treatment with statins
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmus Egede, MD
Organizational Affiliation
Department of Cardiology, Odense University Hospital, Odense, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Odense University Hospital
City
Odense
State/Province
Fuenen
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21349594
Citation
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.
Results Reference
derived
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Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
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