Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II - Study Results

Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II (TOSS-2)

This study has been completed.

Study NCT00130039 Information provided by Asan Medical Center

Study First Received: August 11, 2005 Last Updated: January 4, 2010 History of Changes

Results First Received: October 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Control: Active Control; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Cerebral Infarction Atherosclerosis
Interventions:	Drug: clopidogrel Drug: Cilostazol

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
507 patients were registered www.toss2.com from 20 centers of 4 countries (Korea, Hongkong, Thailand, Philippines). 50 patients were excluded during case verification process because they did not satisfy patient's eligibility criteria. finally 457 patients were randomized into cilostazol or clopidogrel group

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

507 patients were registered www.toss2.com from 20 centers of 4 countries (Korea, Hongkong, Thailand, Philippines). 50 patients were excluded during case verification process because they did not satisfy patient's eligibility criteria.

finally 457 patients were randomized into cilostazol or clopidogrel group

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The excluded patients did not satisfy the definition of the symptomatic stenosis of our study protocol.

Reporting Groups

	Description
Cilostazol	cilostazol 100mg twice a day plus placebo of clopidogrel
Clopidogrel	clopidogrel 75mg per day and matching placebo of cilostazol

Participant Flow: Overall Study

	Cilostazol	Clopidogrel
STARTED	232	225
COMPLETED	202^[1]	207^[2]
NOT COMPLETED	30	18
Withdrawal by Subject	15	11
Lost to Follow-up	3	1
Adverse Event	4	2
Physician Decision	3	0
clinical events without follow up MRI	5	4

[1]	full analysis set
[2]	full analysis set

Baseline Characteristics

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Reporting Groups

	Description
Cilostazol	cilostazol 100mg twice a day plus placebo of clopidogrel
Clopidogrel	clopidogrel 75mg per day and matching placebo of cilostazol

Baseline Measures

	Cilostazol	Clopidogrel	Total
Number of Participants [units: participants]	232	225	457
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	93	112	205
>=65 years	139	113	252
Age [units: years] Mean ± Standard Deviation	66.42 ± 11.33	64.58 ± 11.11	65.52 ± 11.24
Gender [units: participants]
Female	110	113	223
Male	122	112	234
Region of Enrollment [units: participants]
Philippines	5	5	10
Hong Kong	11	12	23
Thailand	6	5	11
Korea, Republic of	210	203	413

Outcome Measures

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1. Primary:

Number of Participants With Progression of Symptomatic Intracranial Stenosis [ Time Frame: 7 months after treatment ]

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2. Secondary:

Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI [ Time Frame: 7 months after treatment ]

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3. Secondary:

Number of Participants With Stroke Events [ Time Frame: upto 7 months after randomization ]

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4. Secondary:

Number of Participants With Overall Cardiovascular Events [ Time Frame: upto 7 months after randomization ]

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5. Secondary:

Number of Patients With Ipsilateral Ischemic Stroke Rate [ Time Frame: upto 7 months after randomization ]

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6. Secondary:

Numbers of Fatal or Major Bleeding Complications [ Time Frame: upto 7 months after randomization ]

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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: Sun U. Kwon, MD, PhD, Prof
Organization: Asan Medical Center, University of Ulsan
phone: 82-2-3010-3960
e-mail: sukwon@amc.seoul.kr

No publications provided

Responsible Party:	Asan Medical Center ( Sun U. Kwon )
Study ID Numbers:	TOSS-2
Study First Received:	August 11, 2005
Results First Received:	October 23, 2009
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00130039 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)