UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004293 |
|---|---|
| Receipt number | R000005147 |
| Scientific Title | Effects of renin-angiotensin system inhibitors for endothelial function and neointimal coverage after drug-eluting stent implantation. ~Comparative study between angiotensin coverting enzyme inhibitors and angiotensin receptor blockers~ |
| Date of disclosure of the study information | 2010/09/29 |
| Last modified on | 2011/09/29 14:12:15 |
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Basic information
Public title
Effects of renin-angiotensin system inhibitors for endothelial function and neointimal coverage after drug-eluting stent implantation. ~Comparative study between angiotensin coverting enzyme inhibitors and angiotensin receptor blockers~
Acronym
Effects of renin-angiotensin system inhibitors for endothelial function and neointimal coverage after drug-eluting stent implantation. ~Comparative study between angiotensin coverting enzyme inhibitors and angiotensin receptor blockers~
Scientific Title
Effects of renin-angiotensin system inhibitors for endothelial function and neointimal coverage after drug-eluting stent implantation. ~Comparative study between angiotensin coverting enzyme inhibitors and angiotensin receptor blockers~
Scientific Title:Acronym
Effects of renin-angiotensin system inhibitors for endothelial function and neointimal coverage after drug-eluting stent implantation. ~Comparative study between angiotensin coverting enzyme inhibitors and angiotensin receptor blockers~
Region
| Japan |
Condition
Condition
Coronary artery disease
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether renin-angiotensin system inhibitors effect on endothelial function and neoitimal coverage after drug-eluting stent implantation, compared between angiotensin converting enzyme inhibitor and angiotensin receptor blocker.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Coronary endothelial function and neointimal coverage 8~10 months after stent implantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Imidapril 10mg once daily
for 8~10 months
Interventions/Control_2
Termisartan 40mg once daily
for 8~10 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stable coronary artery disease
Patients treated with drug-eluting stent
for the first time
Hypertension
Key exclusion criteria
Acute myocardial infarction
Clinical or angiographic coronary
vasospasm
Symptomatic congestive heart failure
Atrial fibrillation
Severe valvular heart disease
Previous coronary bypass graft surgery
Left main coronary artery lesion
Bifurcation lesion
In-stent restenosis lesion
Angiographic in-stent restenosis in
follow-up angiography
Patients who showed progression of
lesions or development of non target
lesions or vessels on follow-up
angiography
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Ueno |
Organization
Kurume University Hospital
Division name
Center of Cardiovascular disease
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-35-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Mitsutake |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine, Division of Cardio-vascular Medicine
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-35-3311
Homepage URL
mitsuhiba@grace.ocn.ne.jp
Sponsor or person
Institute
Department of Internal Medicine,
Division of Cardio-vascular Medicine,
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 29 | 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
| 2009 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 29 | Day |
Last modified on
| 2011 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005147
