Department of Cardiology, Odense University Hospital
Odense, Fuenen, 5000, Denmark
Completed
NCT Number: NCT01245894
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.
Completed
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Conditions
Age range
18 year–81 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- ST-segment elevation myocardial infarction
- no prior treatment with statins and
- a non significant lesion in one of the two non-culprit coronary arteries
Exclusion criteria
- age below 18 or above 81 years,
- unconscious patients,
- serum creatinine > 176μmol/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
Treatment and study plan
Low-dose Rosuvastatin
DrugRosuvastatin 5mg/day for one year
Other names: Crestor
high-dose rosuvastatin
DrugRosuvastatin 40mg/day for one year
Other names: Crestor
Primary outcomes
-
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
Time frame: One year
Secondary outcomes
-
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
Time frame: One year
Sponsors and collaborators
Lead sponsor
Odense University Hospital
Other
Registry information
Official study title
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation
Important dates
- Study start
- 2007
- Primary completion
- 2009
- Study completion
- 2010
- First posted
- Nov 23, 2010
- Registry last updated
- Nov 23, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.