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
1 other identifier
interventional
87
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 28, 2010
CompletedFirst Posted
Study publicly available on registry
January 29, 2010
CompletedJanuary 29, 2010
January 1, 2010
1.6 years
January 28, 2010
January 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline).
One year
Study Arms (2)
Rosuvastatin 5mg
ACTIVE COMPARATORRosuvastatin 5mg/day for one year
Rosuvaststin 40mg
ACTIVE COMPARATORRosuvastatin 40mg/day
Interventions
Eligibility Criteria
You may qualify if:
- ST segment elevation acute myocardial infarction
- % \< angiographic diameter stenosis \< 50% on a not previously revascularized native coronary artery
- Statin naïve
You may not qualify if:
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Odense University Hospital
Odense, Fuenen, 5000, Denmark
Related Publications (3)
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.
PMID: 12390948BACKGROUNDJensen 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.
PMID: 15238460BACKGROUNDEgede 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.
PMID: 22987572DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rasmus Egede, MD
Department of Cardiology, Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 28, 2010
First Posted
January 29, 2010
Study Start
November 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
January 29, 2010
Record last verified: 2010-01