Status:
COMPLETED
The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
National Taiwan University Hospital
Shin Kong Wu Ho-Su Memorial Hospital
Conditions:
Ischemic Stroke
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.
Detailed Description
One thousand patients will be randomized to take cilostazol (500 patients) or placebo (500 patients) in parallel groups. Patients will be screened and evaluated on Visits 1 to assess their eligibility...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT01188824
Start Date
September 1 2010
End Date
July 1 2013
Last Update
October 7 2013
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