UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004065 |
|---|---|
| Receipt number | R000004897 |
| Scientific Title | Binary investigation on the Effects of antiplatelet agents post-PCI: the Necessity of considering vascular Endothelial Function in post coronary Intervention pharmacotherapy |
| Date of disclosure of the study information | 2010/08/18 |
| Last modified on | 2016/02/19 08:25:47 |
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Basic information
Public title
Binary investigation on the Effects of antiplatelet agents post-PCI: the Necessity of considering vascular Endothelial Function in post coronary Intervention pharmacotherapy
Acronym
BENEFIT
Scientific Title
Binary investigation on the Effects of antiplatelet agents post-PCI: the Necessity of considering vascular Endothelial Function in post coronary Intervention pharmacotherapy
Scientific Title:Acronym
BENEFIT
Region
| Japan |
Condition
Condition
Angina pectoris and myocardial infarction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of cilostazol for the vascular endothelial function after stent implantation in patients with ischemic heart disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
FMD(Flow-mediated vasodilatation)
Key secondary outcomes
Target Lesion Revascularization
Target Vessel Revascularization
MACCE(major adverse cardiac-cerebral event)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cilostazol group
Follow up period:6-9 months
Cilostazol
Aspirin
Ticlopidine or clopidogrel
Interventions/Control_2
Control group
Follow up period:6-9 months
Aspirin
Ticlopidine or clopidogrel
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
Patients who were implanted coronary stent
Key exclusion criteria
1)Patients who are bleeding
2)Congestive heart failure
3)Severe hepatic dysfunction or renal dysfunction or medical history of hypersensitivity to the investigational drugs
4)Pregnant or lactating women, or women who wish to become pregnant
5)Pulse rate at rest >= 80/min
6)Receiving warfarin-potassium therapy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyoshi Mori |
Organization
Showa University Fujigaoka Hospital
Division name
Department of Cardiology
Zip code
Address
1-30, Fujigaoka, Aobaku, Yokohama, Kanagawa, Japan
TEL
045-971-1151
hymori@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyoshi Mori |
Organization
Showa University Fujigaoka Hospital
Division name
Department of Cardiology
Zip code
Address
Fujigaoka1-30, Aoba-ku, Yokohama, Kanagawa, Japan
TEL
045-971-1151
Homepage URL
hymori@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Fujigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Fujigaoka Hospital
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
| 2010 | Year | 08 | Month | 18 | 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
| 2010 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | 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
| 2010 | Year | 08 | Month | 18 | Day |
Last modified on
| 2016 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004897
