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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058915
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : January 29, 2010
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Rosuvastatin 5mg Drug: Rosuvastatin 40mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Rosuvastatin 5mg
Rosuvastatin 5mg/day for one year
Drug: Rosuvastatin 5mg
Rosuvastatin 5mg/day
Other Name: Crestor

Active Comparator: Rosuvaststin 40mg
Rosuvastatin 40mg/day
Drug: Rosuvastatin 40mg
Rosuvastatin 40mg/day
Other Name: Crestor

Primary Outcome Measures :
  1. Changes in plaque composition (VH) in a not previously revascularized or infarct related coronary artery with an angiographic insignificant lesion (Follow up - baseline). [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline). [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01058915

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Department of Cardiology, Odense University Hospital
Odense, Fuenen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Rasmus Egede, MD Department of Cardiology Odense University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rasmus Egede, Department of Cardiology, Odense University Hospital, Denmark Identifier: NCT01058915    
Other Study ID Numbers: 2006-003111-43
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010
Keywords provided by Odense University Hospital:
ST-Segment Elevation Myocardial Infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors