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

UMIN ID: C000000028

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: stable angina pectoris with mild hypertension
• Date of first enrollment: 2005/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1) Olmesartan
2) Valsartan

Outcome(s)

• Primary Outcome: nominal 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 minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• 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

• Primary Sponsor: The Department of Cardiology, Nagoya University Graduate School of Medicine
• Source(s) of Monetary Support: The Department of Cardiology, Nagoya University Graduate School of Medicine