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

Odense University Hospital

Status

Completed

Conditions

Acute Coronary Syndrome

Treatments

Drug: Rosuvastatin 5mg

Drug: Rosuvastatin 40mg

Study type

Interventional

Funder types

Other

Identifiers

NCT01058915

2006-003111-43

Details and patient eligibility

About

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).

Enrollment

87 patients

Sex

All

Ages

18 to 81 years old

Volunteers

No Healthy Volunteers

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