UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000129 |
|---|---|
| Receipt number | 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 11:23:54 |
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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
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
otsuka-com@umin.ac.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000190
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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