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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000129
Receipt No. R000000190
Scientific Title Post-marketing study of cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison with Aspirin
Date of disclosure of the study information 2005/09/13
Last modified on 2009/02/09

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Basic information
Public title Post-marketing study of cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison with Aspirin
Acronym Post-marketing study of cilostazol (Cilostazol Stroke Prevention Study II: CSPS II)
Scientific Title Post-marketing study of cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison with Aspirin
Scientific Title:Acronym Post-marketing study of cilostazol (Cilostazol Stroke Prevention Study II: CSPS II)
Region
Japan

Condition
Condition Patients with cerebral infarction (excluding cardiogenic cerebral embolism)
Classification by specialty
Medicine in general Cardiology Neurology
Geriatrics Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Occurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are 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 Cilostazol 200 mg group: Two 50-mg tablets of cilostazol and one aspirin placebo tablet will be administered after a meal in the morning, and two 50-mg tablets of cilostazol, after a meal in the evening. Duration of treatment: Minimum of 1 year and maximum of 5 years
Interventions/Control_2 Aspirin 81 mg group: One 81-mg tablet of aspirin and two cilostazol placebo tablets will be administered after a meal in the morning, and two cilostazol placebo tablets, after a meal in the evening. Duration of treatment: Minimum of 1 year and maximum of 5 years
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1)Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
(2)Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI (3)Patients aged 20 to 80 years (inclusive) at time of consent
(4)Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
(5)Patients without asymptomatic cerebral infarction
(6)Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
(7)Patients without severe disturbances/impairments following occurrence of cerebral
Key exclusion criteria (1)Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
(2)Pregnant, possibly pregnant, or nursing women
(3)Patients with ischemic heart failure
(4)Patients with peptic ulcer
(5)Patients with severer blood disorders
(6)Patients with severe hepatic or renal
(7)Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
(8)Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
(9)Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
(10)Patients who are being treated with ticlopidine hydrochloride
(11)Patients who are participating in another study for an investigational drug(12)Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Target sample size 2600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukito Shinohara
Organization Federation of National Personnel Mutual Aid Associations, Tachikawa Hospital
Division name Internal Medicine
Zip code
Address 4-2-22, Nishiki-cho, Tachikawa, Tokyo, 190-8531, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Department of Clinical and Research Development
Zip code
Address
TEL
Homepage URL
Email otsuka-com@umin.ac.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00234065
Org. issuing International ID_1 CliniclTrials.com
Study ID_2 JapicCTI-050034
Org. issuing International ID_2 Japan Pharmaceutical Information Center
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 13 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
2003 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2003 Year 12 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 11 Month 01 Day
Date analysis concluded
2010 Year 02 Month 01 Day

Other
Other related information Pharmaceuticals and Medical Devices Agency
http://www.info.pmda.go.jp/go/pack/3399002F1028_1_07/Package insert (in Japanese)

Management information
Registered date
2005 Year 09 Month 07 Day
Last modified on
2009 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000190

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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