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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001880
Receipt No. R000002266
Scientific Title Effecacy of anti-platelet drugs after endovascular therapy in patients with femoropopliteal artery disease.
Date of disclosure of the study information 2009/04/13
Last modified on 2015/05/20

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Basic information
Public title Effecacy of anti-platelet drugs after endovascular therapy in patients with femoropopliteal artery disease.
Acronym Effecacy of anti-platelet drugs after EVT for femoropopliteal artery disease.
Scientific Title Effecacy of anti-platelet drugs after endovascular therapy in patients with femoropopliteal artery disease.
Scientific Title:Acronym Effecacy of anti-platelet drugs after EVT for femoropopliteal artery disease.
Region
Japan

Condition
Condition peripheral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effecacy of anti-platelet drugs after endovascular therapy in patients with femoropopliteal artery disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes percent diameter stenosis of the target lesion on angiography
Key secondary outcomes

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sarpogrelate 100mgx3/day, 24weeks
Interventions/Control_2 cilostazol 100mgx3/day, 24weeks
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with successful endovascular therapy for femoropopliteal artery disease (lesional pressure gradient less than 20mmHg or residual percent diameter stenosis less than 50%)
Key exclusion criteria Patients with bleeding tendency or congestive heart failure, or pregnant female.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Hirono
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Cardiology
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL 025-227-2185
Email hirono@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Hirono
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Cardiology
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL 025-227-2185
Homepage URL
Email hirono@med.niigata-u.ac.jp

Sponsor
Institute Division of Cardiology, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Division of Cardiology, Niigata University Graduate School of Medical and Dental Sciences
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
2009 Year 04 Month 13 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 Open public recruiting
Date of protocol fixation
2009 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 13 Day
Last modified on
2015 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002266

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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