UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010347 |
|---|---|
| Receipt number | R000011324 |
| Scientific Title | Angioscopic evaluation of coronary atherosclerotic plaque after revascularization with drug-eluting stent - Intervention trial with statins and cholesterol absorption inhibitors - |
| Date of disclosure of the study information | 2013/03/28 |
| Last modified on | 2014/11/20 23:26:27 |
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Basic information
Public title
Angioscopic evaluation of coronary atherosclerotic plaque after revascularization with drug-eluting stent
- Intervention trial with statins and cholesterol absorption inhibitors -
Acronym
The ANTARES Trial
Scientific Title
Angioscopic evaluation of coronary atherosclerotic plaque after revascularization with drug-eluting stent
- Intervention trial with statins and cholesterol absorption inhibitors -
Scientific Title:Acronym
The ANTARES Trial
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the drug treatments in the color change of plaque after revascularization with coronary drug eluting stent using angioscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The color changes of coronary plaque in 12 months after revascularization with DES
Key secondary outcomes
Grade change of neointimal SMC in culprit lesion with DES
The color change of coronary plaque in non culprit lesion with DES
Thrombosis in culprit lesion with DES
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
Once-daily dosing of pravastatin 10mg and ezetimibe 10mg. If the LDL-C value in 4 weeks has not reached less than 100mg/dL, the titlation of statin dose is repeated at every visit to achieve to the level of less than 100mg/dL.
Interventions/Control_2
Once-daily dosing of rosuvastatin 5mg. If the LDL-C value in 4 weeks has not reached less than 100mg/dL, the titlation of statin dose is repeated at every visit to achieve to the level of less than 100mg/dL.
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
| 25 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Coronary revascularization patients with drug-eluting stent whose LDL-C value is controlled to less than 140mg/dL over 100mg/dL by statin medications, and also whose plaque was observed with angioscopy.
2) Patients less than 85 over 25 years old
3) Unquestioned gender
4) Hospitalization, outpatient unquestioned
Key exclusion criteria
1. Patients within 72 hr after the incidence of acute myocardial infarction.
2. Patients with marked stenosis in the main coronary artery
3. Patients with serum creatinine over 2.0mg/dL.
4. The patients with heart failure which is over NYHA cardiac function classification3, or ejection fraction is less than 40%.
5. The patients with secondary hypercholesterolemia
6. The patients who were daily treated with over 10mg of atorvastatin or 2mg of pitavastatin or 2.5mg of rosuvastatin, and the combination of ezetimibe and statin.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Mizuno |
Organization
Nippon Medical School
Division name
Department of cardiovascular medicine
Zip code
Address
1-1-5, Sendagi, Bunkyo, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Inami Shigenobu |
Organization
Nippon Medical School
Division name
Department of cardiovascular medicine
Zip code
Address
1-1-5, Sendagi, Bunkyo, Tokyo, Japan
TEL
Homepage URL
sigenobu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Advanced Clinical Reserch Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai Rosai Hospital
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
日本医科大学付属病院（東京都）、関西ろうさい病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 10 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2014 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011324
