Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Treatments: Rosuvastatin Calcium

Criteria

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