Clinical trial NCT01188824: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
Official title: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Shin Kong Wu Ho-Su Memorial Hospital
name: Tri-Service General Hospital
name: Far Eastern Memorial Hospital
name: Changhua Christian Hospital
name: Chi Mei Medical Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: E-DA Hospital
name: Mackay Memorial Hospital
name: Cathay General Hospital
name: En Chu Kong Hospital
name: Kuang Tien General Hospital
name: Chung Shan Medical University
name: Taipei Veterans General Hospital, Taiwan
First posted: 2010-08-26
Enrollment: 801
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: The primary endpoint for this study is slowdown of PAD progression based on ABI.
timeFrame: 2 years
Secondary outcomes:
measure: Carotid intima-media thickness
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University Hospital
name: Chung Y. Hsu, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: