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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011371
Receipt No. 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

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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
Institute Department of cardiovascular medicine,The Institute of Health Bio-Sciences,The University of Tokushima Graduate School
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 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
URL(English) https://upload.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


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