- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01058915
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)
January 28, 2010 updated by: Odense University Hospital
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)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fuenen
-
Odense, Fuenen, Denmark, 5000
- Department of Cardiology, Odense University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rosuvastatin 5mg
Rosuvastatin 5mg/day for one year
|
Rosuvastatin 5mg/day
Other Names:
|
Active Comparator: Rosuvaststin 40mg
Rosuvastatin 40mg/day
|
Rosuvastatin 40mg/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline).
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rasmus Egede, MD, Department of Cardiology Odense University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nair A, Kuban BD, Tuzcu EM, Schoenhagen P, Nissen SE, Vince DG. Coronary plaque classification with intravascular ultrasound radiofrequency data analysis. Circulation. 2002 Oct 22;106(17):2200-6. doi: 10.1161/01.cir.0000035654.18341.5e.
- Jensen LO, Thayssen P, Pedersen KE, Stender S, Haghfelt T. Regression of coronary atherosclerosis by simvastatin: a serial intravascular ultrasound study. Circulation. 2004 Jul 20;110(3):265-70. doi: 10.1161/01.CIR.0000135215.75876.41. Epub 2004 Jul 6.
- Egede R, Jensen LO, Hansen HS, Hansen KN, Junker A, Thayssen P. Influence of high-dose lipid lowering treatment compared to low-dose lipid lowering treatment on plaque composition assessed by intravascular ultrasound virtual histology in patients with ST-segment elevation acute myocardial infarction: the VIRHISTAMI trial. EuroIntervention. 2013 Feb 22;8(10):1182-9. doi: 10.4244/EIJV8I10A182.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 28, 2010
First Submitted That Met QC Criteria
January 28, 2010
First Posted (Estimate)
January 29, 2010
Study Record Updates
Last Update Posted (Estimate)
January 29, 2010
Last Update Submitted That Met QC Criteria
January 28, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Acute Coronary Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- 2006-003111-43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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