Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

This study has been completed.

Study NCT00234065 Information provided by Otsuka Pharmaceutical Co., Ltd.

First Received on October 4, 2005. Last Updated on June 9, 2011 History of Changes

Results First Received: April 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Cerebral Infarction
Interventions:	Drug: Cilostazol Drug: Aspirin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with non-cardioembolic ischemic stroke have been recruited at 278 study sites in Japan between December, 2003, and October, 2006.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No screening period

Reporting Groups

	Description
Cilostazol	cilostazol, oral tablet, 100 mg cilostazol
Aspirin	Aspirin, oral tablet, 81 mg aspirin

Participant Flow: Overall Study

	Cilostazol	Aspirin
STARTED	1356	1360
COMPLETED	881	1004
NOT COMPLETED	475	356
Adverse Event	268	166
Withdrawal by Subject	73	56
Physician Decision	23	22
Not Classified	111	112

Baseline Characteristics

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Reporting Groups

	Description
Cilostazol	cilostazol, oral tablet, 100 mg cilostazol
Aspirin	Aspirin, oral tablet, 81 mg aspirin

Baseline Measures

	Cilostazol	Aspirin	Total
Number of Participants [units: participants]	1337	1335	2672
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	681	685	1366
>=65 years	656	650	1306
Age [units: years] Mean ± Standard Deviation	63.5 ± 9.2	63.4 ± 9.0	63.4 ± 9.1
Gender [units: participants]
Female	378	378	756
Male	959	957	1916
Region of Enrollment [units: participants]
Japan	1337	1335	2672

Outcome Measures

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1. Primary:

Numbers of Patients With First Occurence of Stroke [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months]) ]

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2. Secondary:

Number of Patients With First Recurrence of Cerebral Infarction [ Time Frame: From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

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3. Secondary:

Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

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4. Secondary:

Number of Deaths From Any Cause [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

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5. Secondary:

Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

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6. Other Pre-specified:

Number of Patients With First Occurrence of Haemorrhagic Event [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Masahiko Abe, Director Cardiovascular Projects
Organization: Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
phone: +81-6-6943-7722 ext 2545
e-mail: abems@otsuka.jp

Publications of Results:

Shinohara Y, Katayama Y, Uchiyama S, Yamaguchi T, Handa S, Matsuoka K, Ohashi Y, Tanahashi N, Yamamoto H, Genka C, Kitagawa Y, Kusuoka H, Nishimaru K, Tsushima M, Koretsune Y, Sawada T, Hamada C; CSPS 2 group. Cilostazol for prevention of secondary stroke (CSPS 2): an aspirin-controlled, double-blind, randomised non-inferiority trial. Lancet Neurol. 2010 Oct;9(10):959-68. Epub 2010 Sep 15. Review.

Responsible Party:	Katsuhisa Saito, OPCJ
ClinicalTrials.gov Identifier:	NCT00234065 History of Changes
Other Study ID Numbers:	C02100-002, JapicCTI-050034, UMIN-CTR-C000000129
Study First Received:	October 4, 2005
Results First Received:	April 19, 2011
Last Updated:	June 9, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare