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Recruitment status
Unique ID issued by UMIN UMIN000001720
Receipt No. R000002008
Scientific Title Evaluation of the effect of Angiotensin ll receptor blocker for plaque vulnerability after percutaneous coronary intervention (PCI)
Date of disclosure of the study information 2009/02/23
Last modified on 2009/02/12

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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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