UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005597 |
|---|---|
| Receipt number | R000006151 |
| Scientific Title | Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction after Coronary Stenting, A Randomized Controlled Trial |
| Date of disclosure of the study information | 2011/05/13 |
| Last modified on | 2014/05/14 11:56:57 |
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Basic information
Public title
Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction
after Coronary Stenting,
A Randomized Controlled Trial
Acronym
Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction
after Coronary Stenting
(CuVIC Trial)
Scientific Title
Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction
after Coronary Stenting,
A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction
after Coronary Stenting
(CuVIC Trial)
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to elucidate among high risk patients after coronary stenting, whether combination therapy ezetimibe and statin is more effective in improving endotherial function comparing with statin monotherapy, through improvement of lipids profile and lowering oxidative lipids in blood. And whether combination therapy is effective in inhibiting TVD (Target Vessel Dysfunction, as a composit end point, cardiovascular events relating to target coronary vessel and hypercontraction of target coronay vessel).
Then we will contribute to optimization of pharmocological therapy after coronary stenting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Target Vessel Dysfunction, 6-8 months after coronary stenting.
Definition of Target Vessel Dysfunction(TVD) is a composite end point, target vessel-related cardiac death and target vessel-related myocardial infarction and ischemia-driven target vessel revascularization (TVF, Target Vessel Failure) and coronary endotherial dysfunction (positive for Acetylcholine provocation test performed, if no TVF).
Key secondary outcomes
(1) Clinical course
Target Vessel Failure, all cause death, cardiovascular death, cardiac death, coronary artery disease death, resuscitated cardiac arrest, myocardial infarction (MI), non-fatal MI, procedure related MI, non-procedure related MI, revascularization for coronary artery disease, binary restenosis, Canadian Cardiovascular Society Scale and revascularization for peripheral arterial disease
(2) Coronary arterial endotherial function, Peripheral arterial endotherial function
coronary arterial endotherial dysfunction (positive for Acetylcholine provocation test performed, if no TVF)
Ach-related coronary arterial contraction/dilation
endotherial function measured using Endo-PAT (FMD)
(3) Surrogate markers
oxidized cholesterol, oxidized LDL, oxidative stress (TBARS)
lipid profile (T-Chol, TG, LDL, HDL, ApoB, ApoA1)
inflammation marker (hCRP, MCP-1), adiponectine, ROCK activity, PAI-1
(4) Assessment of atherosclerosis
coronary angiogram, in-stent late lumen loss, stenosis at non-target lesion
IVUS. plaque volume, plaque phenotype
PWV/ABI
carotid ultrasound, IMT
coronay CT angiogram, plaque volume, plaque phenotype, perfusion image, pericardial adipose tissue
(5) Assessment of peripheral artery disease
WIQ score, Treadmill test, ABI
(6) Stratified analysis according to the type of stent and subgroup analysis according to the patient backgrounds and things listed above.
(7) Clinical follow-up during 24 months after registration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Statin monotherapy
Interventions/Control_2
Combination therapy ezetmibe 10mg and statin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Satisfy the all conditions below.
(1)After successful coronary stenting(target lesion stenosis<20%).
(2)Written informed consent for this study.
(3)Possible to undertake 6-8 month follow-up coronary angiography at our institutions.
(4)Over 20 years old, male and female.
Key exclusion criteria
Statisfy even one of the conditions below.
(1)Not completed all planned PCI.
(2)Participant of other clinical trial interfering with this study.
(3)Chronic dialysis, chronic liver cirrhosis.
(4)Severely impaired LV function, EF<30%.
(5)Contraindication for statins or ezetimibe.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sunagawa |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5370
cuvic@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Matoba |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5370
Homepage URL
http://www.cuvictrial.com/
cuvic@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine
Kyushu University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine
Kyushu University Graduate School of Medical Sciences
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
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
九州大学病院（福岡県）、麻生飯塚病院（福岡県）、国立病院機構九州医療センター（福岡県）、九州厚生年金病院（福岡県）、佐賀県立病院好生館（佐賀県）、聖マリア病院（福岡県）、浜の町病院（福岡県）、福岡市民病院（福岡県）、福岡赤十字病院（福岡県)、済生会二日市病院（福岡県)、済生会福岡総合病院（福岡県）、原三信病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 09 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 13 | Day |
Last modified on
| 2014 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006151
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