Status:
COMPLETED
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)
Lead Sponsor:
Odense University Hospital
Conditions:
ST-segment Elevation Myocardial Infarction
Subclinical Carotid Atherosclerosis
Eligibility:
All Genders
18-81 years
Phase:
PHASE4
Brief Summary
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate marker of cardiovascula...
Detailed Description
The aim of this study was to measure the effect of moderate (5mg) and intensive (40mg) lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness as a surrogate marker of cardiov...
Eligibility Criteria
Inclusion
- STEMI,
- no prior treatment with statins and
- a non significant lesion in one of the two non-culprit coronary arteries. -
Exclusion
- age below 18 or above 81 years,
- unconscious patients,
- serum creatinine \> 176μmol/L,
- total-cholesterol \> 7.0 mmol/l,
- hypothyroidism ((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. -
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01203982
Start Date
November 1 2007
End Date
June 1 2009
Last Update
September 17 2010
Active Locations (1)
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1
Department of Cardiology, Odense University Hospital
Odense, Fuenen, Denmark, 5000