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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010347
Receipt No. 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

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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
Email

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
Email sigenobu@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011324

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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