NIPH Clinical Trials Search

UMIN ID: C000000028

Registered date:01/04/2006

(Olmesartan and Valsartan Anti-atherosclerosis Trial in Patients with Mild-Hypertension: Using Three-dimensional serial IVUS)Study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedstable angina pectoris with mild hypertension
Date of first enrollment2005/07/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1) Olmesartan 2) Valsartan


Primary Outcomenominal changes in % plaque volumes by three-dimensional intravascular ultrasound at 6-8 months follow-up after percutaneous coronary intervention
Secondary Outcome(IMT) change from baseline in mean IMT after 6-8 months (E/A) change from baseline in E/A after 6-8 months by echocardiography (laboratory test) hs-CRP, adiponectine, aldosterone, renin, oxLDL, HOMA-R, TC, TG, LDL-C, HDL-C, etc

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria(non-lesion related items) 1)Patients with acute coronary syndrome 2)Previous history of Q myocardial infarction within 4 weeks before the randomization 3)Low left ventricular(LV) function(LV ejection fraction < 45%) 4)Patients with renal failure(serum creatinine > 3.0mg) 5)Patients who are treated with angiotensin converting enzyme inhibitor or receptor blocker, or aldosterone receptor blocker at randomization (lesion related items) 1)chronic total coronary artery occlusion 2)lesions on bypass grafts 3)unsuccessful stent implantation (stenosis > 50% after PCI) 4)lesions with prior atheroablative procedures before stent implantation 5)lesions implanted with multiple stents 6)left main trunk lesions 7)lesions on small vessels(reference diameter < 2.0 mm) 8)calcified lesions, which preclude accurate quantification of IVUS imaging

Related Information


public contact
Name Hideki Ishii
Address Japan
Affiliation Nagoya University Graduate School of Medicine The Department of Cardiology
scientific contact
Name Toyoaki Murohara
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan Japan
Affiliation Nagoya University Graduate School of Medicine The Department of Cardiology