UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effect of AngiotensinII receptor blocker on coronary artery after Sirolimus-Eluting Stent implantation
Title of the study (Brief title)	Evaluation of the effect of AngiotensinII receptor blocker on coronary artery after Sirolimus-Eluting Stent implantation
Region	Japan

Condition
Condition	Hypertension with coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the effect of Telmisartan and long-acting calcium channel blocker on coronary artery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Endothelial function by acetylcholine infusion at 3 and 9months follow-up after Sirolimus-Eluting Stent(SES) implantation
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Telmisartan + Fluvastatin sodium
Interventions/Control_2	Long-acting calcium channel blocker + Fluvastatin sodium
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	"1) Patients after Sirolimus-Eluting stent implantation 2) Patients with eligible stenosis (including restenosis) for PCI in 1-2 branch and no stenosis in non-target branch 3) Lesions diameter are 2.5-4.0mm and lesions length are treated by 1 SES 4) Patients who are eligible for IVUS and OCT examinations 5) Hypertensive Patients"
Key exclusion 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%"
Target sample size	50

Research contact person
Name of lead principal investigator	Takahiko Suzuki
Organization	Toyohashi Heart Ceter
Division name	Cardiovascular Medicine
Address	21-1 Gobudori, Oyama-cho, Toyohashi, JAPAN
TEL	0532-37-3377
Email

Public contact
Name of contact person	Mitsuiyasu Terashima
Organization	Toyohashi Heart Ceter
Division name	Cardiovascular Medicine
Address	21-1 Gobudori, Oyama-cho, Toyohashi, JAPAN
TEL	0532-37-3377
Homepage URL
Email

Sponsor
Institute	Toyohashi Heart Ceter, Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 20 Day
Anticipated trial start date	2008 Year 07 Month 01 Day
Last follow-up date	2010 Year 09 Month 01 Day
Date of closure to data entry	2010 Year 12 Month 01 Day
Date trial data considered complete	2011 Year 02 Month 01 Day
Date analysis concluded	2011 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 03 Month 31 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002199