Overview

Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Treatments:
Aspirin
Cilostazol
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