NCT02174939

Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in Coronary Artery Disease

Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells and Endothelial Function Mediated Through Modification of Vasculogenesis and Angiogenesis Factors in Patients With Stable Coronary Artery Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• 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 coronary artery disease (CAD) and cardiovascular high risk. 2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and endothelial function as well as the potential mechanisms of action in patients with CAD and cardiovascular high risk.

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 * subjects with cilostazol and 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. measurement of flow-mediated dilatation (FMD) of left brachial artery by sonography 4. assessment of long-term cardiovascular outcomes

Conditions

• Coronary Artery Disease

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: 2014-02-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2014-06-26
• Last updated: 2015-10-14

Locations

1 site across 1 country: Taiwan