NCT01188824

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Cilostazol	100 mg, bid p.o.
OTHER	placebo	1 tablet, bid

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-08-26
• Last updated: 2013-10-07