UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001720 |
|---|---|
| Receipt number | 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 14:43:10 |
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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
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
Sponsor or person
Institute
The University of Tokushima, Cardiovascular Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002008
