Rationale and design of the EPISTEME trial: efficacy of post-stroke intensive rosuvastatin treatment for aortogenic embolic stroke.
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).
Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu, Chiba, 279-0021, Japan, yuji-u@juntendo.ac.jp.
Yuji
Y
Ueno
Kazuo
K
Yamashiro
Yasutaka
Y
Tanaka
Masao
M
Watanabe
Yoshiaki
Y
Shimada
Takuma
T
Kuroki
Nobukazu
N
Miyamoto
Masao
M
Daimon
Ryota
R
Tanaka
Katsumi
K
Miyauchi
Hiroyuki
H
Daida
Nobutaka
N
Hattori
Takao
T
Urabe
D001011:Aorta / Q000473:pathology; D002545:Brain Ischemia / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D017548:Echocardiography, Transesophageal; D004617:Embolism / Q000150:complications; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000150:complications / Q000188:drug therapy; D058226:Plaque, Atherosclerotic / Q000150:complications / Q000188:drug therapy; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D000068718:Rosuvastatin Calcium; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium