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

China Medical University

Status and phase

Completed

Phase 4

Conditions

Ischemic Stroke

Treatments

Other: placebo

Drug: Cilostazol

Study type

Interventional

Funder types

Other

Identifiers

NCT01188824

DMR99-IRB-137

Details and patient eligibility

About

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.

Full 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 prior to randomization. The treatment period (Visit 1-6) will last 12 months and the patient will receive initial and follow-up evaluation (section 4.5) including history and physical examinations, and baseline and end of treatment ABI and carotid IMT assessments. Vascular events and death as well as adverse events including bleeding complications will also be recorded at intervals as detailed in section 4.5.

Enrollment

801 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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