Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)
Not Applicable
Completed
- Conditions
- Acute Coronary Syndrome
- Interventions
- Registration Number
- NCT01058915
- Lead Sponsor
- Odense University Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
- ST segment elevation acute myocardial infarction
- 20% < angiographic diameter stenosis < 50% on a not previously revascularized native coronary artery
- Statin naïve
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rosuvastatin 5mg Rosuvastatin 5mg Rosuvastatin 5mg/day for one year Rosuvaststin 40mg Rosuvastatin 40mg Rosuvastatin 40mg/day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline). One year
Trial Locations
- Locations (1)
Department of Cardiology, Odense University Hospital
🇩🇰Odense, Fuenen, Denmark