Rationale and design of a study to examine lower targets for low-density lipoprotein-cholesterol and blood pressure in coronary artery disease patients.
BACKGROUND
The benefits of coronary risk modification through medication and other methods have been shown in many clinical studies. Recently, aggressive lowering of low-density lipoprotein-cholesterol (LDL-C) has been shown to confer additive benefits in patients with coronary artery disease (CAD). However, it has not been shown in Japanese patients with CAD if multiple aggressive medical interventions for coronary risk factors are beneficial compared with standard regimens, so a prospective, randomized, open-label, blinded-endpoint (PROBE) multicenter study was designed to evaluate whether aggressive lowering of LDL-C and blood pressure in Japanese hypertensive, hypercholesterolemic CAD patients bestows additional benefits compared with regimens based on current Japanese guidelines.


RESULTS
Seventeen hospitals in Japan are participating in the Japanese Coronary Artery Disease II (JCADII) study. Hypertensive and hypercholesterolemic patients who have >or=75% stenosis in at least one major coronary artery according to American Heart Association guidelines will be allocated randomly to receive either conventional or aggressive therapy. Standard therapy for hypertension and hypercholesterolemia aims to reduce blood pressure to <140/90 mmHg and LDL-C concentration to <100 mg/dl. Aggressive therapy aims for targets of <120/80 mmHg and <80 mg/dl, respectively. We plan to recruit 500 patients and follow them up for 3 years. Antihypertensive agents, when used, include the angiotensin receptor blockers candesartan and/or losartan. Antihypercholesterolemic agents, when used, include at least one of the following statins: pravastatin, simvastatin, and atorvastatin.


CONCLUSIONS
The JCADII study will provide important information concerning medical treatment of coronary risk factors in Japanese patients with CAD (UMIN-ID: UMIN000000571).
Nagai
Ryozo
R
Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Izumi
Tohru
T
Kurabayashi
Masahiko
M
Daida
Hiroyuki
H
Tojo
Taiki
T
Hasegawa
Akira
A
Miyauchi
Katsumi
K
Hayashi
Dobun
D
Kohro
Takahide
T
Okada
Yoshihiro
Y
Yamazaki
Tsutomu
T
D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D008078:Cholesterol, LDL / Q000097:blood*; D002985:Clinical Protocols; D003324:Coronary Artery Disease / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D007564:Japan; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D012307:Risk Factors
D000959:Antihypertensive Agents; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors