Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo university (ALPS-J).
OBJECTIVE
Many trials have shown that calcium channel blockers (CCBs) can reduce the cardiovascular (CV) events in patients with coronary artery disease (CAD). The mechanisms of this effect could be associated with plaque regression due to the anti-atherosclerotic properties of CCBs. The goal of this study is to determine the effects of CCB on volumetric quantitative changes of coronary plaques accessed by intravascular ultrasound (IVUS). To confirm this hypothesis, a multicenter randomized trial of CCBs treatment with azelnidipine or amlodipine will be conducted in hypertensive CAD patients undergoing elective percutaneous coronary intervention (PCI).


RESULTS
Patients who have hypertension and are scheduled for PCI will be enrolled. Subjects will be randomized to azelnidipine or amlodipine and observed for 48 weeks. The primary endpoint will be the percent change of coronary plaque volume. The secondary endpoint will include inflammatory markers, antioxidant activity, and incidence of composite cardiovascular events.


CONCLUSIONS
In this study, we will investigate the improvement of coronary plaque with IVUS by treatment with two dihydropyridine CCBs in hypertensive patients undergoing elective PCI. This result will lead to the discovery of more effective drug therapy for inhibition of coronary events.
Miyauchi
Katsumi
K
Department of Cardiology, Juntendo University School of Medicine, Tokyo, Japan.
Kojima
Takahiko
T
Yokoyama
Takayuki
T
Kurata
Takeshi
T
Yokoyama
Ken
K
Kawamura
Masaki
M
Suwa
Satoru
S
Okazaki
Shinya
S
Inoue
Kenji
K
Fujiwara
Yasumasa
Y
Sumiyoshi
Masataka
M
Tanimoto
Kosei
K
Nakazato
Yuji
Y
Yamagami
Shinichiro
S
Daida
Hiroyuki
H
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D001383:Azetidinecarboxylic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000150:complications / Q000000981:diagnostic imaging* / Q000517:prevention & control*; D004095:Dihydropyridines / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D014463:Ultrasonography; D055815:Young Adult
D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D017311:Amlodipine; D001383:Azetidinecarboxylic Acid; C061679:azelnidipine