Evaluation of the effect of AngiotensinII receptor blocker on coronary artery after Sirolimus-Eluting Stent implantation

UMIN ID: UMIN000001822

Registered date:31/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension with coronary artery disease
• Date of first enrollment: 2008/07/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Telmisartan + Fluvastatin sodium
Long-acting calcium channel blocker + Fluvastatin sodium

Outcome(s)

• Primary Outcome: Endothelial function by acetylcholine infusion at 3 and 9months follow-up after Sirolimus-Eluting Stent(SES) implantation
• Secondary Outcome: 1) Intima proliferation and vascular healing of lesion that SES implantation by Optical Coherence Tomography(OCT)at 9months follow-up 2) Plaque composition of non-target lesion by Virtual Histology IVUS at 9months follow-up 3) Coronary collateral function by flow Pressure combination wire at 3 and 9months follow-up 4) Change in surrogate marker TNF-alpha,hs-CRP,IL-6,Adiponectin,Total, LDL, HDL-Cho,Triglyceride,Sitosterol,Campesterol,Lathosterol,Apo A-1,Apo B,Apo E

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: "1) Patients with coronary vasospasm 2) Patients who have lesions that are applicable to exclusion criteria 3) Previous cerebrovascular event <= 6month 4) Severe gastrointestinal bleeding <= 3month 5) Patients who contraindicate antithronbotic and anticoagulant therapy 6) Patients who have severe allergy to contrast dye 7) Ejection fraction <= 30%&quot

Related Information

• Primary Sponsor: Toyohashi Heart Ceter, Cardiovascular Medicine
• Source(s) of Monetary Support: Japan Vascular Disease Research Foundation