UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effect of Angiotensin ll receptor blocker for plaque vulnerability after percutaneous coronary intervention (PCI)
Acronym	Telmisartan for plaque regression
Scientific Title	Evaluation of the effect of Angiotensin ll receptor blocker for plaque vulnerability after percutaneous coronary intervention (PCI)
Scientific Title:Acronym	Telmisartan for plaque regression
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 effect of Telmisartan and non-RAS blocker on Plaque vulnerability
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Change in plaque composition and observation by Integrated Backscatter Intravascular Ultrasound (IB-IVUS)
Key secondary outcomes	1) Change in surrogate marker in coronary vein blood hs-CRP,IL-6,TNF-alpha,IP-10,MMP-3, MMP-9,MCP-1,MIF,PTX-3,Heparin cofactor 2) Office blood pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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 + Pravastatin sodium
Interventions/Control_2	Antiypertensive agents except RAS blocker + Pravastatin 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 bere-metal stent implantation, confirmed>=75% stenosis in 1-2 branch by angiography 2) Lesions diameter>=3mm 3) Patients with metabolic syndrome 4) Patients with hypertension 5) LDL cholesterol level>=100mg/dl
Key exclusion criteria	1) Previous storoke<=6month 2) Ejection fraction<=40% 3) Patients with dialysis 4) Diabetic patients with HbA1c<=6.5 5) Patients who are treated with statin except pravastatin sodium
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masataka SATA
Organization	The University of Tokushima
Division name	Cardiovascular Medicine
Zip code
Address	3-18-15 Kuramoto-Cho Tokushima
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The University of Tokushima Institute of Health Biosciences Graduate School
Division name	Cardiovascular Medicine
Zip code
Address
TEL	088-633-7852
Homepage URL
Email

Sponsor
Institute	The University of Tokushima, Cardiovascular Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation	2009 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date	2009 Year 02 Month 01 Day
Last follow-up date	2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 02 Month 20 Day
Last modified on	2009 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002008

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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