UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004016 |
|---|---|
| Receipt number | R000004827 |
| Scientific Title | Kumamoto-PrevEntioN cilosTazol Acute proGressiON stroke |
| Date of disclosure of the study information | 2010/08/10 |
| Last modified on | 2011/08/08 09:15:45 |
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Basic information
Public title
Kumamoto-PrevEntioN cilosTazol Acute proGressiON stroke
Acronym
Kumamoto-PENTAGON Study
Scientific Title
Kumamoto-PrevEntioN cilosTazol Acute proGressiON stroke
Scientific Title:Acronym
Kumamoto-PENTAGON Study
Region
| Japan |
Condition
Condition
Brain infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Aspirin versus Cilostazol in the prevention of acute progressing stroke
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Incidence of the progressing stroke (worsening of the NIHSS score by 2 point or more)
Key secondary outcomes
1)Proportion of the patients with mRS score 0,1 or 2 at 3 months follow-up
2)Incidence of cardiovascular events
3)Incidence of hemorrhagic adverse events
4) Incidence of adverse events
(without hemorrhagic stroke)
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 considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aspirin group: aspirin 200mg/day
Three months
Interventions/Control_2
Cilostazol group: cilostazol 200mg/day
Three months
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
(1) Non-cardioembolic brain infarction
(2) First or recurrent stroke
(3) Within 48 hours after the onset
(4) Patients who develop symptoms within 48 hours before starting the administration of the investigational drugs
(5) Stable general condition
Key exclusion criteria
(1) Cardioembolic brain infarction
(2) Contraindications to aspirin or cilostazol
1) Patients with hemorrhagic disease
2) Patients with Congestive heart failure
3) Patients known hypersensitivity to aspirin or cilostazol
4) Patients with pregnancy or potential pregnancy
5) Patients with active peptic ulcer
6) Patients with aspirin-induced asthma
7) Low birth weight infant, newborn and infant
(3) Patients who should be treated with rt-PA
(4) Patient who is taking aspirin or cilostazol at the time of admission
(5) Patients who are considered unsuitable for inclusion in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruyuki Hirano |
Organization
Kumamoto University
Division name
Department of Neurology
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5893
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruyuki Hirano |
Organization
Kumamoto University
Division name
Department of Neurology
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5896
Homepage URL
http://www.freeml.com/k-pentagon
k-pentagon@freeml.com
Sponsor or person
Institute
Kumamoto Acute Stroke Study Group
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
熊本市民病院（熊本県）, 熊本赤十字病院（熊本県）, 済生会熊本病院（熊本県）, 熊本医療センター（熊本県）,熊本大学（熊本県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 08 | Day |
Last modified on
| 2011 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004827
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
