Rationale and design for a study using intravascular ultrasound to evaluate effects of rosuvastatin on coronary artery atheroma in Japanese subjects: COSMOS study (Coronary Atherosclerosis Study Measuring Effects of Rosuvastatin Using Intravascular Ultrasound in Japanese Subjects).
BACKGROUND
There have been few multicenter studies using intravascular ultrasound (IVUS) to assess the process of atherosclerosis in a Japanese population with hypercholesterolemia that is being treated with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors for control of low-density lipoprotein-cholesterol.


RESULTS
An open-label multicenter study is planned to evaluate with IVUS whether treatment with rosuvastatin for 76 weeks results in regression of coronary artery atheroma volume in patients who have coronary heart disease (CHD) and hypercholesterolemia. Sample size is 200 subjects with CHD who are to undergo percutaneous coronary intervention. The planned duration is between October 2005 and October 2008.


CONCLUSIONS
The COSMOS study will be the first multicenter cardiovascular study in a Japanese population and may provide new evidence on the effects of rosuvastatin on the progression of coronary atherosclerotic lesions.
Takayama
Tadateru
T
Division of Cardiovascular Medicine, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Hiro
Takafumi
T
Yamagishi
Masakazu
M
Daida
Hiroyuki
H
Saito
Satoshi
S
Yamaguchi
Tetsu
T
Matsuzaki
Masunori
M
D000328:Adult; D000368:Aged; D050197:Atherosclerosis / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D018450:Disease Progression; D005464:Fluorobenzenes / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008875:Middle Aged; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D018084:Ultrasonography, Interventional / Q000009:adverse effects / Q000379:methods*
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium