Phase 4 Completed N=244 Randomized Quadruple-blind Treatment

Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

cerebral infarction

Source: ClinicalTrials.gov NCT00446641 ↗

Enrolled (actual)

244

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcomePrimary: Aspirin Resistance (ARU ≥ 550) — 9; 11 participants — p=0.654

Summary

This study will recruit 316 ischemic stroke patients taking aspirin. They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month. The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.

Outcome Measures

Outcome	Result	p-value
PRIMARY Aspirin Resistance (ARU ≥ 550)	9; 11	0.654
SECONDARY Aspirin Resistance (ARU ≥ 500)	20; 28	—
SECONDARY Bleeding Time (BT)	113; 106	—
SECONDARY Fatal or Major Bleeding Complications;	0; 0	—
SECONDARY Any Bleeding Complications	0; 0	—
SECONDARY Difference of Post-treatment ARU and Baseline ARU	-7.8; 12.1	—
SECONDARY Post-treatment ARU	454.8; 473.6	—

Eligibility Criteria

Inclusion Criteria

Symptomatic cerebral infarction documented on MRI or CT
More than 35 years of age
Patients taking aspirin 100mg a day for 2 weeks or more before randomization

Exclusion Criteria

Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
Patients taking any anticoagulants within 2 weeks before randomization
Patients taking thrombolytic therapy within 2 weeks before randomization
Patients taking any NSAIDs within 2 weeks before randomization
Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
Bleeding diathesis
Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
Pregnant or lactating patients
Patients scheduled for angioplasty or revascularization procedures within 4 weeks
Patients scheduled for any surgery or invasive procedures within 4 weeks
Patients having acute coronary syndrome

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Data sourced from ClinicalTrials.gov (NCT00446641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.