The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed.
- Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD
- Neurologically and clinically stable at inclusion
- PAD (i.e. ankle-brachial index or ABI <1.0)

Exclusion Criteria

- Patients unable to give informed consent
- Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others)
- Modified Rankin Scale >4
- Patients with history of dementia requiring institutional care
- Known brain tumor
- Known anemia (defined as hemoglobin <10.0 g/dL)
- Known thrombocytopenia (defined as platelet count below 100,000/cm3)
- AST or ALT > 3 x Upper Normal Limit
- Calculated creatinine clearance < 30 ml/min according to the Copckroft formula)
- Known hemostasis or coagulation disorder
- Congestive heart failure, defined as a previous definitive diagnosis, or present symptoms of at least Category II of the NYHA classification system for CHF
- Revascularization of the lower limb arteries including bypass surgery, endovascular procedures
- Symptomatic PAD requiring treatment with cilostazol
- Known stenosis of the upper limb arteries that may affect the documentation of ABI
- Patients with known hypersensitivity to cilostazol