UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007728 |
|---|---|
| Receipt number | 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 22:00:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009026
