UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011934
Receipt number R000013936
Scientific Title The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT
Date of disclosure of the study information 2013/10/01
Last modified on 2014/04/01 15:57:18

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Basic information

Public title

The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT

Acronym

The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT

Scientific Title

The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT

Scientific Title:Acronym

The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT

Region

Japan


Condition

Condition

Ischemic heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to assess the impact of EPA or ezetimibe therapy on the stabilization of vulnerable plaques, using OCT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fibrous-cap thickness and lipid burden in vulnerable plaque assessed by OCT

Key secondary outcomes

The incidence of death, revascularization, myocardial infarction for 2 years


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

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients received daily 1800mg EPA and ordinary statin therapy for 2 years.

Interventions/Control_2

The patients received daily 10mg ezetimibe and ordinary statin therapy for 2 years.

Interventions/Control_3

The patients received ordinary statin therapy for 2 years.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who underwent percutaneous coronary intervention (PCI) for ischemic heart diseases and having LDL levels > 100 mg/dL without lipid-lowering therapy. Of them, the patients who had vulnerable plaque were enrolled in this study.

Key exclusion criteria

Patients were excluded from the study if they (1) were already using statins or other lipid-lowering therapies, (2) had known hypersensitivity to statins or contrast, (3) had end-stage renal failure (serum creatinine [Cre] &#8805; 2.0 mg/dL), (4) demonstrated hemodynamic and respiratory instability (e.g., cardiogenic shock, severe congestive heart failure), or (5) had no consent to participate.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiro Shinke

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular and Respiratory Medicine, Department of Internal Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

TEL

078-382-5846

Email

shinke@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryo Nishio

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular and Respiratory Medicine, Department of Internal Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

TEL

078-382-5846

Homepage URL


Email

ryo_ni_19_81_7@hotmail.com


Sponsor or person

Institute

Kobe 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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24637411

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

Main results already published

Date of protocol fixation

2009 Year 08 Month 06 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2013 Year 12 Month 15 Day

Date of closure to data entry

2013 Year 12 Month 15 Day

Date trial data considered complete

2013 Year 12 Month 15 Day

Date analysis concluded

2013 Year 12 Month 20 Day


Other

Other related information



Management information

Registered date

2013 Year 10 Month 01 Day

Last modified on

2014 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013936


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name