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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007728
Receipt No. R000009026
Scientific Title Effect of Olmesartan on Endothelial Dysfunction After Everolimus Eluting Stent Implantation
Date of disclosure of the study information 2012/04/11
Last modified on 2015/04/11

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Basic information
Public title Effect of Olmesartan on Endothelial Dysfunction After Everolimus Eluting Stent Implantation
Acronym Effect of Olmesartan on Endothelial Dysfunction After Everolimus Eluting Stent Implantation
Scientific Title Effect of Olmesartan on Endothelial Dysfunction After Everolimus Eluting Stent Implantation
Scientific Title:Acronym Effect of Olmesartan on Endothelial Dysfunction After Everolimus Eluting Stent Implantation
Region
Japan

Condition
Condition hypertension and coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy of olmesartan on endothelial dysfunction after everolimus eluting stent implantation. The endothelial function is evaluated using intracoronary infusion of acetylcholine after 9 months from the stent implantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes endothelial function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Olmesartan group
Olmesartan is administered up to 40mg/day. If not effective, calcium channel blocker, beta blocker, diuretic, alpha blocker will be added.
Interventions/Control_2 Non olmesartan group
Amlodipine is administered up to 10mg/day. ACE inhibitor, ARB is prohibited. If not effective, other calcium channel blocker, beta blocker, diuretic, alpha blocker will be added.
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 1. Hypertensive patients planned to implant drug eluting stent.
2. Patients who are admitted to our hospital.
Key exclusion criteria 1. Recent myocardial infarction (within the previous 48 hours).
2. An ejection fraction of less than 40%.
3. An unprotected left main coronary artery disease.
4. A history of coronary artery vasospasm.
5. Severe calcified or adherence of thrombus in target vessel.
6. Bilateral renal artery stenosis or unilateral renal artery stenosis of remnant kidney.
7. Hyperkalemia (serum kalium>5.0mEq/L).
8. Renal insufficiency (serum creatinnin > 3.0 mg/dL).
9. Liver function disorder (AST or ALT > 100 U/L).
10. Expectant mother.
11. Inappropriate patients judged by the physician in charge.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Aoki
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address 1-8-1 Inohana Chuo-ku Chiba-shi Chiba 260-8670 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address 1-8-1 Inohana Chuo-ku Chiba-shi Chiba 260-8670 Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Science and Medicine, Chiba University Graduate School of 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 YES
Study ID_1 G23071
Org. issuing International ID_1 Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 11 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
2012 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 11 Day
Last modified on
2015 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009026

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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