Rationale and design of the EPISTEME trial: efficacy of post-stroke intensive rosuvastatin treatment for aortogenic embolic stroke.

Abstract

BACKGROUND:

Large atheromatous aortic plaques (AAPs) are associated with stroke recurrence. Rosuvastatin is a potent lipid-lowering agent and suppresses carotid and coronary artery atherosclerosis. It is unclear whether rosuvastatin has anti-atherogenic effects against AAPs in stroke patients. We designed a clinical trial in stroke patients to analyze changes in AAPs after rosuvastatin treatment using repeated transesophageal echocardiography (TEE).

METHODS:

This trial is a prospective randomized open label study. Inclusion criteria were patients were ischemic stroke with hypercholesterolemia and AAPs ≥ 4 mm in thickness. The patients are randomly assigned to either a group treated with 5 mg/day rosuvastatin or a control group. Primary endpoint is the changes in volume and composition of AAPs after 6 months using transesophageal echocardiography (TEE). Biochemical findings are analyzed. By using repeated TEE and binary image analysis, we will be able to compare the dynamic changes in plaque composition of AAPs before and after therapy in the two groups.

CONCLUSIONS:

The EPISTEME trial will provide information on the changes in plaque volume and composition achieved by improvement of lipid profiles with rosuvastatin therapy in stroke patients with aortic atherosclerosis. The results of the study may provide evidence for a therapeutic strategy for aortogenic brain embolism. This study is registered with UMIN-CTR (UMIN000010548).

• Authors: Yuji Ueno, Kazuo Yamashiro, Yasutaka Tanaka, Masao Watanabe, Yoshiaki Shimada, Takuma Kuroki, Nobukazu Miyamoto, Masao Daimon, Ryota Tanaka, Katsumi Miyauchi, Hiroyuki Daida, Nobutaka Hattori, Takao Urabe
• Journal: Cardiovascular drugs and therapy (Cardiovasc Drugs Ther) Vol. 28 Issue 1 Pg. 79-85 (Feb 2014) ISSN: 1573-7241 [Electronic] United States
• PMID: 24072337 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Fluorobenzenes
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Pyrimidines
• Sulfonamides
• Rosuvastatin Calcium

Topics

• Aorta (pathology)
• Brain Ischemia (drug therapy, etiology, pathology)
• Echocardiography, Transesophageal
• Embolism (complications)
• Fluorobenzenes (administration & dosage, therapeutic use)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage, therapeutic use)
• Hypercholesterolemia (complications, drug therapy)
• Plaque, Atherosclerotic (complications, drug therapy)
• Prospective Studies
• Pyrimidines (administration & dosage, therapeutic use)
• Research Design
• Rosuvastatin Calcium
• Stroke (drug therapy, etiology, pathology)
• Sulfonamides (administration & dosage, therapeutic use)