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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004016
Receipt No. 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

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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
Email

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
Email k-pentagon@freeml.com

Sponsor
Institute Kumamoto Acute Stroke Study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004827

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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