Overcome Biochemical Aspirin Resistance Through Cilostazol Combination - Study Results

Overcome Biochemical Aspirin Resistance Through Cilostazol Combination (ARCC)

This study has been completed.

Study NCT00446641 Information provided by Asan Medical Center

First Received on March 12, 2007. Last Updated on December 10, 2009 History of Changes

Results First Received: January 22, 2009

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: Treatment
Condition:	Cerebral Infarction
Interventions:	Drug: Cilostazol Drug: placebo

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
244 patients with subacute or chronic ischemic stroke were recruited from outpatient clinics of 5 comprehensive stroke centers of Korea

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with aspirin therapy were recruited due to subacute or chronic ischemic stroke. The patients should have taken aspirin 100mg per day at least 2 weeks before randomization

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patients with aspirin therapy were recruited due to subacute or chronic ischemic stroke.

The patients should have taken aspirin 100mg per day at least 2 weeks before randomization

Reporting Groups

	Description
Cilostazol	Cilostazol 100mg twice per day
Placebo	matching placebo to cilostazol

Participant Flow: Overall Study

	Cilostazol	Placebo
STARTED	125	119
COMPLETED	108	109
NOT COMPLETED	17	10
Withdrawal by Subject	8	3
poor compliance	8	6
Lost to Follow-up	1	1

Baseline Characteristics

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Reporting Groups

	Description
Cilostazol	Cilostazol 100mg twice per day
Placebo	matching placebo to cilostazol

Baseline Measures

	Cilostazol	Placebo	Total
Number of Participants [units: participants]	125	119	244
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	75	71	146
>=65 years	50	48	98
Age [units: years] Mean ± Standard Deviation	61.24 ± 10.198	62.83 ± 9.963	62.02 ± 10.095
Gender [units: participants]
Female	36	41	77
Male	89	78	167
Region of Enrollment [units: participants]
Korea, Republic of	125	119	244

Outcome Measures

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1. Primary:

Aspirin Resistance (ARU ≥ 550) [ Time Frame: 4 weeks after treatment ]

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2. Secondary:

Aspirin Resistance (ARU ≥ 500) [ Time Frame: 4 weeks after reatment ]

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3. Secondary:

Bleeding Time (BT) [ Time Frame: 4 weeks after reatment ]

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4. Secondary:

Fatal or Major Bleeding Complications; [ Time Frame: events ocurred during study medication after randomization ]

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5. Secondary:

Any Bleeding Complications [ Time Frame: events ocurred during study medication after randomization ]

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6. Secondary:

Difference of Post-treatment ARU and Baseline ARU [ Time Frame: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication ]

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7. Secondary:

Post-treatment ARU [ Time Frame: after 4 weeks treatment ]

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

No publications provided

Responsible Party:	Sun U. Kwon, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00446641 History of Changes
Other Study ID Numbers:	ARCC
Study First Received:	March 12, 2007
Results First Received:	January 22, 2009
Last Updated:	December 10, 2009
Health Authority:	Korea: Food and Drug Administration