UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001198 |
|---|---|
| Receipt number | R000001434 |
| Scientific Title | Cilostazol trial |
| Date of disclosure of the study information | 2008/06/20 |
| Last modified on | 2008/06/19 08:11:41 |
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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 ≤ 0.9
3) a percentage stenosis diameter of ≥ 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
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
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001434
