UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005078 |
|---|---|
| Receipt number | R000006031 |
| Scientific Title | The effects of ezetimibe on malondialdehyde-modified low-density lipoprotein in abnormal glucose tolerance patients with coronary artery disease |
| Date of disclosure of the study information | 2011/02/15 |
| Last modified on | 2011/02/14 15:01:01 |
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Basic information
Public title
The effects of ezetimibe on malondialdehyde-modified low-density lipoprotein in abnormal glucose tolerance patients with coronary artery disease
Acronym
The effects of ezetimibe on MDA-LDL in abnormal glucose tolerance patients with coronary artery disease
Scientific Title
The effects of ezetimibe on malondialdehyde-modified low-density lipoprotein in abnormal glucose tolerance patients with coronary artery disease
Scientific Title:Acronym
The effects of ezetimibe on MDA-LDL in abnormal glucose tolerance patients with coronary artery disease
Region
| Japan |
Condition
Condition
Coronaty artery disease with diabetes, including impaired glucose torelance
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oxidised low-density lipoprotein cholesterol (ox-LDL) is a new marker that was shown to better predict cardiovascular risk than standard lipid parameters.
Ezetimibe and statins were shown in few studies to reduce atherogenic ox-LDL cholesterol beyond LDL cholesterol lowering, and no clinical trial has been performed to investigate the differential effects among the drugs.
The aim of this study is to examine the differential effects on blood sugar and plasma lipid, including malondialdehyde-modified LDL, among ezetimibe and atorvastatin in abnormal glucose tolerance patients with coronary artery disease utilizing cross-over design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change and percent change in MDA-LDL
Key secondary outcomes
Change and percent change in TC, LDL-C, TG, and HDL-C.
Change and percent change in HbA1c
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Administration of atorvastatin 20mg in the first 3 months, followed by the administration of atorvastatin 10mg and ezetimibe 10mg
Interventions/Control_2
Administration of atorvastatin 10mg and ezetimibe 10mg in the first 3 months, followed by the administration of atorvastatin 20mg
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
1) Patients who have a history of following coronary heart diseases;
CABG or PCI was performed more than 6 months before
>= 50% coronary artery stenosis according to the ACC/AHA classification was found by CAG
2) Diabetic patients under treatment or patients who diagnosed with diabetic (inclucing IGT; 2-hour plasma/serum glucose level: 140mg/dL to 199mg/dL) at 75g oral glucose tolerance test
3) Patients who take atorvastatin 10mg more than 3 months
4) Patients who are judged to require the more lipid-lowering therapy
Key exclusion criteria
1) Patients with history of acute coronary syndrome within 6 months
2) Patients with inflammatory disease, infectious disease, and malignancy
3) Patients with history of hypersensitivity against ezetimibe and atorvastatin
4) Pregnant women, women who may be pregnant, and breast-feeding women.
5) Patients with severe liver dysfunction or renal dysfunction
6) Insulin-treated diabetic patients
7) Patients judged by the investigator/ sub investigator to be ineligible for some other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Watarai |
Organization
Cardiovascular Center, Anjo Kosei Hospital
Division name
Division of Cardiology
Zip code
Address
28 Higashi-hirokute, Anjo-cho, Anjo-city, Aichi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Cardiovascular Center, Anjo Kosei Hospital
Division name
Division of Cardiology
Zip code
Address
28 Higashi-hirokute, Anjo-cho, Anjo-city, Aichi
TEL
Homepage URL
Sponsor or person
Institute
Cardiovascular Center, Anjo Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 15 | 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
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 14 | Day |
Last modified on
| 2011 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006031
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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