UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001822 |
|---|---|
| Receipt number | R000002199 |
| Scientific Title | Evaluation of the effect of AngiotensinII receptor blocker on coronary artery after Sirolimus-Eluting Stent implantation |
| Date of disclosure of the study information | 2009/03/31 |
| Last modified on | 2018/09/20 10:41:59 |
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Basic information
Public title
Evaluation of the effect of AngiotensinII receptor blocker on coronary artery after Sirolimus-Eluting Stent implantation
Acronym
Evaluation of the effect of AngiotensinII receptor blocker on coronary artery after Sirolimus-Eluting Stent implantation
Scientific Title
Evaluation of the effect of AngiotensinII receptor blocker on coronary artery after Sirolimus-Eluting Stent implantation
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takahiko Suzuki |
Organization
Toyohashi Heart Ceter
Division name
Cardiovascular Medicine
Zip code
Address
21-1 Gobudori, Oyama-cho, Toyohashi, JAPAN
TEL
0532-37-3377
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuiyasu Terashima |
Organization
Toyohashi Heart Ceter
Division name
Cardiovascular Medicine
Zip code
Address
21-1 Gobudori, Oyama-cho, Toyohashi, JAPAN
TEL
0532-37-3377
Homepage URL
Sponsor or person
Institute
Toyohashi Heart Ceter, Cardiovascular Medicine
Institute
Department
Personal name
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)
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 | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 20 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002199
