Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Official Title: “Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients”

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.

[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

Intervention(s) in this Clinical Trial

• Drug: Cilostazol
  • cilostazol 100mg twice a day for 4 weeks
• Drug: placebo
  • placebo 1 tablet twice a day matching for cilostazol

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1 Cilostazol
  • 100mg of Cilostazol twice a day
• Placebo Comparator: Placebo
  • matching placebo to cilostazol

Primary Measures

• Aspirin Resistance (ARU ≥ 550)
  • Time Frame: 4 weeks after treatment
    Safety Issue?: No

Secondary Measures

• Aspirin Resistance (ARU ≥ 500)
  • Time Frame: 4 weeks after reatment
    Safety Issue?: No
• Bleeding Time (BT)
  • Time Frame: 4 weeks after reatment
    Safety Issue?: Yes
• Fatal or Major Bleeding Complications;
  • Time Frame: events ocurred during study medication after randomization
    Safety Issue?: Yes
• Any Bleeding Complications
  • Time Frame: events ocurred during study medication after randomization
    Safety Issue?: Yes
• 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
    Safety Issue?: No
• Post-treatment ARU
  • Time Frame: after 4 weeks treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Asan Medical Center Other

Overall Clinical Trial Officials and Contacts

Sun U Kwon, MD. PhD. Principal Investigator Asan Medical Center, Univsersity of Ulsan, Medical College  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00446641

Study ID Number: ARCC

ClinicalTrials.gov Identifier: NCT00446641

Health Authority: Korea: Food and Drug Administration