UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011371
Receipt number R000013050
Scientific Title Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention
Date of disclosure of the study information 2013/08/06
Last modified on 2013/08/03 20:51:54

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Basic information

Public title

Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention

Acronym

The efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine

Scientific Title

Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention

Scientific Title:Acronym

The efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine

Region

Japan


Condition

Condition

Patients undergoing percutaneous coronary intervention, complicated with dyslipidemia and who are treated with statins under at least six months or more

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study compares the effect on coronary plaque and inflammatory cytokine of statin therapy to that of statin combined with LOTRIGA in patients undergoing percutaneous coronary intervention

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of changes in plaque formation before and after medication by integrated backscatter intravascular ultrasound (IB-IVUS)

Key secondary outcomes

Changes in blood inflammation markers


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Continuing statin

Interventions/Control_2

Combined application of LOTRIGA 4g a day

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1)Patients in which stenosis is found to exceed 75% in 1-2 vessels, prompting implantation of a stent by percutaneous coronary intervention (PCI)
2)Age of patients is 20 years or older and less than 85 years
3)Patients of LDL cholesterol of 100 or less mg/dl, and who are treated with statin (under at least six months or more)
4)Patients who is possible to follow up for 6-8 months after PCI
5)Sex does not ask
6)Patients without the administration schedule of the supplement containing n-3 polyunsaturated fatty acid during exam time
7)Patients who have given written informed consent

Key exclusion criteria

1)Patients with a past history of hypersensitivity to LOTRIGA
2)Patients suffering a stroke within the previous 6 months
3)Patients with a left vetricular ejection fraction of 40% or less
4)Patients on dialysis
5)Patients with bleeding (hemophilia, capilary fragility, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhaging etc.)
6)Patients with peptic ulcers
7)Patients considered unsuitable for other reasons

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masataka Sata

Organization

The Institute of Health Bio-Sciences,The University of Tokushima Graduate School

Division name

Department of cardiovascular medicine

Zip code


Address

3-18-15, Kuramoto-cho

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Koji Yamaguchi

Organization

Tokushima university hospital

Division name

Department of cardiovascular

Zip code


Address

2-50-1, Kuramoto-cho

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of cardiovascular medicine,The Institute of Health Bio-Sciences,The University of Tokushima Graduate School

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 08 Month 06 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

Preinitiation

Date of protocol fixation

2013 Year 05 Month 14 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 30 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

2013 Year 08 Month 05 Day

Last modified on

2013 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013050


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name