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

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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 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


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

Value
https://center6.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