UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009629 |
|---|---|
| Receipt number | R000011299 |
| Scientific Title | Effects of antiplatelet drugs for coronary endothelial functions after drug-eluting stent placement |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2012/12/25 21:48:20 |
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Basic information
Public title
Effects of antiplatelet drugs for coronary endothelial functions after drug-eluting stent placement
Acronym
Effects of antiplatelet drugs for coronary endothelial functions after drug-eluting stent placement
Scientific Title
Effects of antiplatelet drugs for coronary endothelial functions after drug-eluting stent placement
Scientific Title:Acronym
Effects of antiplatelet drugs for coronary endothelial functions after drug-eluting stent placement
Region
| Japan |
Condition
Condition
Patients, complicated with peripheral arterial occlusive disease, without in-stent stenosis eight months after drug-eluting stent implantation in the left anterior descending coronary
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of effects on intimal reformation in the drug-eluting stent and endothelial function after stenting between clopidogrel and cilostazol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1. At the start of the study and eight months later, evaluation of either presence or absence of in-stent stenosis in left anterior descending coronary, judging whether new stenotic lesion exists in the left anterior descending coronary by angiography, and determination of stenosis rate by QCA
2. At the start of the study and eight months later, evaluation of vascular reactivity within 20 mm from distal end of in-stent in left anterior descending coronary by load test using acetylcholine and determination of average vessel diameter by QCA
3. At the start of the study and eight months later, evaluation of degree of in-stent intimal thickening (neo-intimal volume %) in left anterior descending coronary by OCT
Key secondary outcomes
1. At the start of the study and eight months later, judging whether new stenotic lesion exists in left circumflex coronary by angiography and determination of stenosis rate by QCA
2. At the start of the study and eight months later, evaluation of vascular reactivity within 20 mm from bifurcation of left circumflex coronary artery, or within 20 mm from distal end of in-stent in left anterior descending coronary in case of stent implanted in the range of evaluation, by load test using acetylcholine, and determination of average vessel diameter by QCA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: administration of cilostazol (200 mg per day) and aspirin (100mg per day) for eight months
Interventions/Control_2
Group B: administration of clopidogrel (75 mg per day) and aspirin (100mg per day) for eight 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who meet all of the following criteria:
1. Stable angina patients with chronic arterial occlusive disease between the ages of 20 and 80 years old
2. Asymptomatic patients who underwent drug-eluting stent implantation in left anterior descending coronary and had in-stent stenosis rate of less than 50% in contrast study after eight months
3. Patients with heart rate is less than 80 beats per minute
4. Patients follow-up can be more than eight months
5. Patients who receive an explanation of the study, the consent of the study participants was obtained in writing from the person or agent
Key exclusion criteria
Subjects who fall under any of the following criteria will be excluded from this study
1. Patients with bleeding or bleeding tendency
2. Patients treated with antiplatelet drugs is not appropriate
3. Patients with a history of hypersensitivity or side effects caused by the study drugs
4. Patients with malapposition on OCT image
5. Patients without visible coating on stent surface on OCT image
6. Patients otherwise judged by the investigator to be inappropriate for inclusion in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Sata |
Organization
The Institute of Health Biosciences, The University of Tokushima Graduate School
Division name
Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-7851
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuzo Wakatsuki |
Organization
Tokushima University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima, Japan
TEL
088-633-7851
Homepage URL
wakatuki@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
The Institute of Health Biosciences, The University of Tokushima Graduate School
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
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
徳島大学病院（徳島県） Tokushima University Hospital (Tokushima)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 25 | Day |
Last modified on
| 2012 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011299
