Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)
NCT ID: NCT01058915
Last Updated: 2010-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2007-11-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rosuvastatin 5mg
Rosuvastatin 5mg/day for one year
Rosuvastatin 5mg
Rosuvastatin 5mg/day
Rosuvaststin 40mg
Rosuvastatin 40mg/day
Rosuvastatin 40mg
Rosuvastatin 40mg/day
Interventions
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Rosuvastatin 5mg
Rosuvastatin 5mg/day
Rosuvastatin 40mg
Rosuvastatin 40mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 20% \< angiographic diameter stenosis \< 50% on a not previously revascularized native coronary artery
* Statin naïve
Exclusion Criteria
* Atrial fibrillation, not well rate-controlled
* Ventricle frequency variation with more than a factor 2 over 1 minute
* Unconscious patients
* Total cholesterol \> 7.0 mmol/l
* History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins) including rosuvastatin
* Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (a serum-human chorionic gonadotrophin \[Beta-HCG\] analysis)
* History of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin, or in the case of a study designed to investigate antineoplastic properties of rosuvastatin. Women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear Papanicolaou (Pap) smears
* Uncontrolled hypothyroidism (TSH \> 1.5xULN)
* Abnormal LFT's
* History of alcohol or drug abuse within the last 5 years (this may affect compliance)
* Current active liver disease (ALT/SGPT \>2xULN or severe hepatic impairment (to protect patient safety as directed on the labels of currently approved statins)
* Unexplained creatine kinase (CK \> 3xULN) (To protect patient safety) (will be increased at baseline because of acute ST segment elevation myocardial infarction a few days before enrolment)
* Serum creatinine \>176mmol/L (2.0mg/dL) (unless the protocol specifically aims to investigate a chronic renal disease population)
* Participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events)
* Treatments with cyclosporine
* Treatment with gemfibrozil
18 Years
81 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Department of Cardiology, Odense University Hospital, Denmark
Principal Investigators
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Rasmus Egede, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Odense University Hospital
Locations
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Department of Cardiology, Odense University Hospital
Odense, Fuenen, Denmark
Countries
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References
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Nair A, Kuban BD, Tuzcu EM, Schoenhagen P, Nissen SE, Vince DG. Coronary plaque classification with intravascular ultrasound radiofrequency data analysis. Circulation. 2002 Oct 22;106(17):2200-6. doi: 10.1161/01.cir.0000035654.18341.5e.
Jensen LO, Thayssen P, Pedersen KE, Stender S, Haghfelt T. Regression of coronary atherosclerosis by simvastatin: a serial intravascular ultrasound study. Circulation. 2004 Jul 20;110(3):265-70. doi: 10.1161/01.CIR.0000135215.75876.41. Epub 2004 Jul 6.
Egede R, Jensen LO, Hansen HS, Hansen KN, Junker A, Thayssen P. Influence of high-dose lipid lowering treatment compared to low-dose lipid lowering treatment on plaque composition assessed by intravascular ultrasound virtual histology in patients with ST-segment elevation acute myocardial infarction: the VIRHISTAMI trial. EuroIntervention. 2013 Feb 22;8(10):1182-9. doi: 10.4244/EIJV8I10A182.
Other Identifiers
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2006-003111-43
Identifier Type: -
Identifier Source: org_study_id