Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)

Acute Coronary Syndrome Clinical Trial

— VIRHISTAMI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058915
• Other study ID #: 2006-003111-43
• Status: Completed
• Phase: N/A
• First received: January 28, 2010
• Last updated: January 28, 2010
• Start date: November 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Rosuvastatin 5mg
Rosuvastatin 5mg/day
• Rosuvastatin 40mg
Rosuvastatin 40mg/day

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Odense University Hospital	Odense	Fuenen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. Epub 2004 Jul 6. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline).		One year	No