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

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01058915

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Rosuvastatin 5mg Drug: Rosuvastatin 40mg	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rosuvastatin 5mg Rosuvastatin 5mg/day for one year	Drug: Rosuvastatin 5mg Rosuvastatin 5mg/day Other Names: Crestor
Active Comparator: Rosuvaststin 40mg Rosuvastatin 40mg/day	Drug: Rosuvastatin 40mg Rosuvastatin 40mg/day Other Names: Crestor

Arm

Intervention/Treatment

Active Comparator: Rosuvastatin 5mg

Rosuvastatin 5mg/day for one year

Drug: Rosuvastatin 5mg

Rosuvastatin 5mg/day

Other Names:

Crestor

Active Comparator: Rosuvaststin 40mg

Rosuvastatin 40mg/day

Drug: Rosuvastatin 40mg

Rosuvastatin 40mg/day

Other Names:

Crestor

Outcome Measures

Primary Outcome Measures

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

Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline). [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 81 Years

Sexes Eligible for Study:

All

Accepts 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