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)
This study has been completed.
Sponsor:
Odense University Hospital
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01058915
First received: January 28, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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Purpose
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 | Intervention |
|---|---|
|
Acute Coronary Syndrome |
Drug: Rosuvastatin 5mg Drug: Rosuvastatin 40mg |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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) |
Resource links provided by NLM:
Further study details as provided by Odense University Hospital:
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). [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline). [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 87 |
| Study Start Date: | November 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 81 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058915
Locations
| Denmark | |
| Department of Cardiology, Odense University Hospital | |
| Odense, Fuenen, Denmark, 5000 | |
Sponsors and Collaborators
Odense University Hospital
Investigators
| Principal Investigator: | Rasmus Egede, MD | Department of Cardiology Odense University Hospital |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rasmus Egede, Department of Cardiology, Odense University Hospital, Denmark |
| ClinicalTrials.gov Identifier: | NCT01058915 History of Changes |
| Other Study ID Numbers: | 2006-003111-43 |
| Study First Received: | January 28, 2010 |
| Last Updated: | January 28, 2010 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Odense University Hospital:
|
ST-Segment Elevation Myocardial Infarction |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Acute Coronary Syndrome Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Angina Pectoris Chest Pain |
Pain Signs and Symptoms Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013