UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001782
Receipt No. R000002142
Scientific Title Intensive LOwering of BlOod low-density lipoprotein ChOlesterol with statin + ezetimibe therapy improves cardiac function after Percutaneous coronary intervention in patients with coronary stenting in Fukuoka-II (LOBOCOP-II)
Date of disclosure of the study information 2009/03/23
Last modified on 2012/03/17

* 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 Intensive LOwering of BlOod low-density lipoprotein ChOlesterol with statin + ezetimibe therapy improves cardiac function after Percutaneous coronary intervention in patients with coronary stenting in Fukuoka-II
(LOBOCOP-II)
Acronym Intensive LOwering of BlOod low-density lipoprotein ChOlesterol therapy improves cardiac function after coronary stenting in Fukuoka-II
(LOBOCOP-II)
Scientific Title Intensive LOwering of BlOod low-density lipoprotein ChOlesterol with statin + ezetimibe therapy improves cardiac function after Percutaneous coronary intervention in patients with coronary stenting in Fukuoka-II
(LOBOCOP-II)
Scientific Title:Acronym Intensive LOwering of BlOod low-density lipoprotein ChOlesterol therapy improves cardiac function after coronary stenting in Fukuoka-II
(LOBOCOP-II)
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 is to examine whether an intensive lipid lowering therapy with statin + ezetimibe is more effective than a converntional therapy with statin in a significant reduction of coronary restenosis or coronary ischemic events as assessed by coronary angiogram(CAG), intravascular ultrasound(IVUS). multi-slice CT(MSCT). Contrast echocardiogram. flow mediated dilatation, cardio ankle vascular index and pulse wave velocity. Biochemical markers, such as adhesion molecules, chemokines, adipocytokines, matrix metalloproteinases and tissue inhibitor of metalloproteinase in blood are also analyzed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Evaluation of %DS by QCA(6-9 months after PCI)
%DS:percent diameter stenosis
QCA:quantitative coronary angiography
Key secondary outcomes Plaque volume by IVUS, Plaque area by MSCT, LV blood flow by the contrast echocardiography, the plaque by the carotid echo, a vascular endothelium function by FMD, the evaluation of the change of ,adhesion molecule. The measurement of blood levels of chemokine, MMP(Matrix Metalloproteinase), TIMP(Tissue Inhibitor of Metalloproteinase), adiponectine.
Major adverse cardiac events (MACE) and target lesion revascularization (TLR) during follow up.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 From administration of the atorvastatin(10mg/day) and ezetimibe(10mg/day) to follow up coronary
arteriography by PCI(after 6-9 months).
Blood sampling is performed before PCI and after PCI at day 1, 7 and 6-9
months.

Interventions/Control_2 From administration of the atorvastatin(10mg/day) to follow up coronary
arteriography by PCI(after 6-9 months).
Blood sampling is performed before PCI and after PCI at day 1, 7 and 6-9
months.
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria The subjects include the patients who did not receive statin before coronary stent implantation and are successfully implanted with a stent at Fukuoka University Hospital.
Key exclusion criteria Patients with familial hyperlipidaemia, a severe liver dysfunction (AST / ALT more than the double of the reference value), severe renal dysfunction (Cr more than 2mg/dl), diabetes mellitus inadequate control (HbA1c more than 7mg/dl), the possibility of pregnancy, and a history of hypersensitivity for the ingredient of the study drug are excluded from the study.The patients who fall under the contraindication of the study drug and the inappropriate patients by doctor's judgement are also excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keijirou Saku
Organization Fukuoka University Hospital
Division name Circulatory organ internal medicine
Zip code
Address 7-45-1,nanakuma,jounan-ku,fukuoka-city,fukuoka
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadaaki Arimura,Makoto sugihara
Organization Fukuoka University Hospital
Division name Circulatory organ internal medicine
Zip code
Address 7-45-1,nanakuma,jounan-ku,fukuoka-city,fukuoka
TEL 092-801-1011
Homepage URL
Email

Sponsor
Institute Heart/vascular internal medicine,fukuoka university
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2009 Year 03 Month 23 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
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 17 Day
Last modified on
2012 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.