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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004065
Receipt No. 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

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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
Email 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
Email hymori@med.showa-u.ac.jp

Sponsor
Institute Showa University Fujigaoka Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004897

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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