UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004611 |
|---|---|
| Receipt number | R000005504 |
| Scientific Title | Efficacy and safety of change the antiplatelet agent in patients with chronic noncardioembolic ischemic stroke - multi-center prospective study - |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2017/02/23 13:20:48 |
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Basic information
Public title
Efficacy and safety of change the antiplatelet agent in patients with chronic noncardioembolic ischemic stroke
- multi-center prospective study -
Acronym
Efficacy and safety of change the antiplatelet agent in patients with chronic noncardioembolic ischemic stroke
Scientific Title
Efficacy and safety of change the antiplatelet agent in patients with chronic noncardioembolic ischemic stroke
- multi-center prospective study -
Scientific Title:Acronym
Efficacy and safety of change the antiplatelet agent in patients with chronic noncardioembolic ischemic stroke
Region
| Japan |
Condition
Condition
noncardioembolic ischemic stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of change from aspirin to cilostazol in patients with chronic noncardioembolic ischemic stroke
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Episode of headache, palpitation, tachycardia.
Key secondary outcomes
1. Withdrawal for adverse effect. (headache, palpitation, tachycardia)
2. Episode of adverse effect to exclusion of headache, palpitation, tachycardia.
3.Change of mRS.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with cilostazol group(100mg-200mg/day)
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with noncardioembolic ischemic stroke.
2. Patients with stroke of Primary or recurrent.
3. Patient's Symptoms of stroke is stable when obtaining consent
4. Patients who agreed to participate with the written informed consent.
Key exclusion criteria
1. Patients with cardioembolic ischemic stroke.
2. Patients with hemorrhage or bleeding tendency.
3. Patients with congestive heart failure.
4. Patients with a history of hypersensitivity to ingredients of cilostazol.
5. Pregnant, possibly pregnant, or nursing women.
6. Patients on cilostazol
7. Patients with CAS for asymptomatic stroke.
8. Patients during the argatroban, ozagrel sodium or scheduled.
9. Patients during the rt-PA or scheduled.
10. Patients with scheduled on neuroendovascular therapy.
11. Patients on experimental drug or scheduled.
12. Patients who are otherwise judged inappropriate for inclusion in the study by the investigators.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Uno |
Organization
Kawasaki Medical School Hospital
Division name
Neurosurgery
Zip code
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
muno@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Uno |
Organization
Kawasaki Medical School Hospital
Division name
Neurosurgery
Zip code
Address
Neurosurgery
TEL
086-462-1111
Homepage URL
muno@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Neurosurgery,Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, School of Medicien
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
川崎医科大学附属病院（岡山県）、さとう記念病院（岡山県）、長谷川紀念病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | 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 | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005504
