NCT01952756

Effect of Cilostazol Endothelial Progenitor Cells and Collateral Formation in Peripheral Occlusive Artery Disease (PAOD)

Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells and Collateral Formation Assessed by Dual-energy 128-row CT Angiography Mediated Through Multiple Mechanisms in Patients With Mild-to-moderate PAOD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases such as PAOD. 2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of action in patients with mild-to-moderate PAOD.

Detailed description

1. titration of drugs 1. run-in period: eligible subjects are screened and baseline blood samples are obtained 2. study period: 12 weeks * 24 subjects with cilostazol and 20 subjects with dummy placebo * On the first day after the end of the study period, the follow-up data are obtained by the same procedure 3. blood sampling and measurement of serum biomarkers * obtained from peripheral veins in all study subjects at the run-in period and the end of the treatment period of the study * sent for isolation, cell culture, and assays of human EPCs * also stored for enzyme-linked immunosorbent assay (Stromal cell derived factor-alfa1, adiponectin, soluble thrombomodulin, vascular endothelial growth factor) 2. assays of human EPCs 1. colony formation by EPCs 2. quantification of EPCs and apoptotic endothelial cells 3. chemotactic motility, proliferation/viability and apoptosis assays 3. collateral vessels formation and distal run-off assessed by dual-energy multi-slice computed tomography angiography 4. echocardiographic examinations to evaluate left ventricular functions

Conditions

• Peripheral Arterial Diseases

Interventions

Type	Name	Description
DRUG	Cilostazol	One tablet (100 mg) twice per day for 12 weeks
DRUG	Dummy Placebo	One tablet twice per day for 12 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-09-30
• Last updated: 2014-07-18

Locations

1 site across 1 country: Taiwan