Acute Coronary Syndrome
Conditions
Keywords
ST-Segment Elevation Myocardial Infarction
Brief summary
In patients with ST-segment elevation acute myocardial infarction (STEMI) increased LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization (changes in plaque composition) and plaque regression over 12 months beyond the benefit of moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and VH).
Interventions
DRUGRosuvastatin 5mg
Rosuvastatin 5mg/day
Rosuvastatin 40mg/day
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
* ST segment elevation acute myocardial infarction * 20% \< angiographic diameter stenosis \< 50% on a not previously revascularized native coronary artery * Statin naïve
Exclusion criteria
* Pharmacologic lipid lowering treatment before index hospitalization * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in plaque composition (VH) in a not previously revascularized or infarct related coronary artery with an angiographic insignificant lesion (Follow up - baseline). | One year |
Secondary
| Measure | Time frame |
|---|---|
| Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline). | One year |
Countries
Denmark
Outcome results
None listed