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

Completed

Phase 4 Results N/A

Trial Description

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

Interventions

  • Cilostazol (PletalĀ®)Drug
    Other Names: Claudiasil
    Intervention Desc: 100 mg, bid p.o.
    ARM 1: Kind: Experimental
    Label: Cilostazol
  • Placebo Drug
    Intervention Desc: 1 tablet, bid
    ARM 1: Kind: Experimental
    Label: placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoint for this study is slowdown of PAD progression based on ABI. 2 years No
Secondary Carotid intima-media thickness 2 years Yes

Sponsors