Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

[Goal] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.

[Trial Design] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial

[Participants] Ischemic stroke patients taking aspirin

[Methods]

• Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
• Investigational product: Cilostazol 200mg (100mg twice per day)
• Concomitant medication: Aspirin 100 mg per day
• Medication Duration: 1 month

[Outcome Variables]

Primary Outcome Variable:

• the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA

Secondary outcome variables:

• the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA
• ARUs values
• Bleeding time (BT)
• Fatal or major bleeding complications
• Any bleeding complications

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