UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004950
Receipt No. R000005888
Scientific Title Acute aspirin plus cilostazol Dual Therapy for non-cardioembolic stroke patients within 48 h of symptom onset -a prospective, multicenter, randomized, an aspirin-controlled study-
Date of disclosure of the study information 2011/06/02
Last modified on 2014/10/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Acute aspirin plus cilostazol Dual Therapy for non-cardioembolic stroke patients within 48 h of symptom onset -a prospective, multicenter, randomized, an aspirin-controlled study-
Acronym Acute aspirin plus cilostazol Dual Therapy for non-cardioembolis stroke
Scientific Title Acute aspirin plus cilostazol Dual Therapy for non-cardioembolic stroke patients within 48 h of symptom onset -a prospective, multicenter, randomized, an aspirin-controlled study-
Scientific Title:Acronym Acute aspirin plus cilostazol Dual Therapy for non-cardioembolis stroke
Region
Japan

Condition
Condition Non cardioembolic stroke
Classification by specialty
Neurology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of antiplatelet(aspirin plus cilostazol) dual therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes modified Rakin scale score at 3 months after stroke
neurological worsening within 14 days of stroke onset
TIA, stroke reccurence, intracerebral hemorrhage, subarachnoid hemorrhage within 14 days of stroke onset
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 From May 2011 to April 2013
aspirin plus cilostazol group
aspirin 81-200mg plus cilostazol 200mg
Interventions/Control_2 From May 2011 to April 2013
aspirin group
aspirin 81-200mg
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria non-cardioembolic stroke within 48 hours of onset
NIHSS score on admission 20 points or over
preadmission mRS score 0-2
Key exclusion criteria cardioembolic stroke
preadmission antithrombotic therapy (cilostazol, aspirin 200mg or over, clopidgrel, ticlopidine, anticoagulants)
congestive heart failure
pregnancy
allergy
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Inoue
Organization Kawasaki Medical School
Division name Stroke Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Email inouet@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Inoue
Organization Kawasaki Medical School
Division name Stroke Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email inouet@med.kawasaki-m.ac.jp

Sponsor
Institute Stroke Medicine Kawasaki Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2011 Year 06 Month 02 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 Open public recruiting
Date of protocol fixation
2011 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 25 Day
Last modified on
2014 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005888

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.