UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001782 |
|---|---|
| Receipt number | 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 15:35:04 |
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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
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
Sponsor or person
Institute
Heart/vascular internal medicine,fukuoka university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002142
