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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001198
Receipt No. R000001434
Scientific Title Cilostazol trial
Date of disclosure of the study information 2008/06/20
Last modified on 2008/06/19

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Basic information
Public title Cilostazol trial
Acronym Cilostazol trial
Scientific Title Cilostazol trial
Scientific Title:Acronym Cilostazol trial
Region
Japan

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

Objectives
Narrative objectives1 To determine whether cilostazol would reduce target vessel revascularization in patients after femoropopliteal stenting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes target vessel revascularization
Key secondary outcomes major adverse cardiovascular event, restenosis rate

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 Aspirin 81-100mg/day
Interventions/Control_2 Aspirin 81-100mg/day + cilostazol 200mg/day
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)PAD patients with intermittent claudication who had a de novo femoropopliteal disease without an inflow lesion (aortoiliac or common femoral lesion), with an outflow artery (below the knee arteries) with more than one vessel run-off, and with symptoms that were not improved by pharmacotherapy or exercise therapy
2) ankle-brachial index (ABI) of &#8804; 0.9
3) a percentage stenosis diameter of &#8805; 50% by visual estimate on angiography
Key exclusion criteria previous lower extremity bypass surgery, previous EVT in the femoropopliteal artery, acute onset limb ischemia, or severe lower extremity ischemic symptoms classified into Rutherford Category 4, 5 or 6, known bleeding diathesis, hepatic dysfunction, active gastrointestinal bleeding or peptic ulcer disease, intolerance to cilostazol, aspirin or ticlopidine, pregnant women and women of child-bearing potential, and major life-threatening illness.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyoshi Yokoi
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address 1-1 Kifune-machi Kokurakita-ku Kitakyusyu city Fukuoka Japan
TEL 093-921-2231
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kokura Memorial Hospital
Division name cardiology
Zip code
Address 1-1 Kifune-machi Kokurakita-ku Kitakyusyu city Fukuoka Japan
TEL 093-921-2231
Homepage URL
Email

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

Funding Source
Organization none
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
2008 Year 06 Month 20 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
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 19 Day
Last modified on
2008 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001434

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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