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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004293
Receipt No. 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

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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
Email

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
Email mitsuhiba@grace.ocn.ne.jp

Sponsor
Institute Department of Internal Medicine,
Division of Cardio-vascular Medicine,
Kurume University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005147

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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