UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of change the antiplatelet agent in patients with chronic noncardioembolic ischemic stroke - multi-center prospective study -
Title of the study (Brief title)	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	Masaaki Uno
Organization	Kawasaki Medical School Hospital
Division name	Neurosurgery
Address	577, Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Email	muno@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Masaaki Uno
Organization	Kawasaki Medical School Hospital
Division name	Neurosurgery
Address	Neurosurgery
TEL	086-462-1111
Homepage URL
Email	muno@med.kawasaki-m.ac.jp

Sponsor
Institute	Neurosurgery,Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005504