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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: ST-Segment Elevation Myocardial Infarction
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Changes in plaque composition (VH) in a not previously revascularized or infarct related coronary artery with an angiographic insignificant lesion (Follow up - baseline).
timeFrame: One year
Secondary outcomes:
measure: Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline).
timeFrame: One year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
state: Fuenen
Study officials:
affiliation: Department of Cardiology, Odense University Hospital
name: Rasmus Egede, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.