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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Collaborators: Cathay General Hospital; Changhua Christian Hospital; Chi Mei Medical Hospital; Chung Shan Medical University; E-DA Hospital; En Chu Kong Hospital; Far Eastern Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; Kuang Tien General Hospital; Mackay Memorial Hospital; National Cheng-Kung University Hospital; National Taiwan University Hospital; Shin Kong Wu Ho-Su Memorial Hospital; Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital
• Treatments: Cilostazol

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