Trial Outcomes & Findings for Overcome Biochemical Aspirin Resistance Through Cilostazol Combination (NCT NCT00446641)

NCT ID: NCT00446641

Last Updated: 2010-01-18

Results Overview

The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 244 participants
• Primary outcome timeframe: 4 weeks after treatment
• Results posted on: 2010-01-18

Participant Flow

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

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

Participant milestones

Measure	Cilostazol Cilostazol 100mg twice per day	Placebo matching placebo to cilostazol
Overall Study STARTED	125	119
Overall Study COMPLETED	108	109
Overall Study NOT COMPLETED	17	10

Reasons for withdrawal

Measure	Cilostazol Cilostazol 100mg twice per day	Placebo matching placebo to cilostazol
Overall Study Withdrawal by Subject	8	3
Overall Study poor compliance	8	6
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Baseline characteristics by cohort

Measure	Cilostazol n=125 Participants Cilostazol 100mg twice per day	Placebo n=119 Participants matching placebo to cilostazol	Total n=244 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	71 Participants n=7 Participants	146 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Age Continuous	61.24 years STANDARD_DEVIATION 10.198 • n=5 Participants	62.83 years STANDARD_DEVIATION 9.963 • n=7 Participants	62.02 years STANDARD_DEVIATION 10.095 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	78 Participants n=7 Participants	167 Participants n=5 Participants
Region of Enrollment Korea, Republic of	125 participants n=5 Participants	119 participants n=7 Participants	244 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after treatment

The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients

Outcome measures

Measure	Cilostazol n=108 Participants Cilostazol 100mg twice per day	Placebo n=109 Participants matching placebo to cilostazol
Aspirin Resistance (ARU ≥ 550)	9 participants	11 participants

SECONDARY outcome

Timeframe: 4 weeks after reatment

The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values

Outcome measures

Measure	Cilostazol n=108 Participants Cilostazol 100mg twice per day	Placebo n=109 Participants matching placebo to cilostazol
Aspirin Resistance (ARU ≥ 500)	20 participants	28 participants

SECONDARY outcome

Timeframe: 4 weeks after reatment

for evaluation of the extent of the bleeding time prolongation by additional cilostazol

Outcome measures

Measure	Cilostazol n=108 Participants Cilostazol 100mg twice per day	Placebo n=109 Participants matching placebo to cilostazol
Bleeding Time (BT)	113 seconds Standard Deviation 38.5	106 seconds Standard Deviation 34.2

SECONDARY outcome

Timeframe: events ocurred during study medication after randomization

Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood

Outcome measures

Measure	Cilostazol n=108 Participants Cilostazol 100mg twice per day	Placebo n=109 Participants matching placebo to cilostazol
Fatal or Major Bleeding Complications;	0 participants	0 participants

SECONDARY outcome

Timeframe: events ocurred during study medication after randomization

any bleeding events causing medical attention

Outcome measures

Measure	Cilostazol n=108 Participants Cilostazol 100mg twice per day	Placebo n=109 Participants matching placebo to cilostazol
Any Bleeding Complications	0 participants	0 participants

SECONDARY outcome

Timeframe: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication

summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients

Outcome measures

Measure	Cilostazol n=108 Participants Cilostazol 100mg twice per day	Placebo n=109 Participants matching placebo to cilostazol
Difference of Post-treatment ARU and Baseline ARU	-7.8 change of ARU measured Standard Deviation 77.6	12.1 change of ARU measured Standard Deviation 71.1

SECONDARY outcome

Timeframe: after 4 weeks treatment

mean of ARU value of individual participants after 4 weeks treatment

Outcome measures

Measure	Cilostazol n=108 Participants Cilostazol 100mg twice per day	Placebo n=109 Participants matching placebo to cilostazol
Post-treatment ARU	454.8 ARU Standard Deviation 52.8	473.6 ARU Standard Deviation 63.9

Adverse Events

Cilostazol

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cilostazol n=125 participants at risk Cilostazol 100mg twice per day	Placebo n=119 participants at risk matching placebo to cilostazol
Nervous system disorders headache	5.6% 7/125 • Number of events 7	1.7% 2/119 • Number of events 2

Additional Information

Professor Sun U. Kwon

Asan Medical Center, University of Ulsan College of Medicine

Phone: 82-2-3010-3960

Email: sukwon@amc.seoul.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place