Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in High Risk for Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Official title: Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells Mediated Through Multiple Mechanisms in Patients With High Risk for Cardiovascular Disease

Status Completed

Clinical Trial Summary

1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases.

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 high risk for cardiovascular disease.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

• NCT number: NCT02194686
• Study type: Interventional
• Source: National Cheng-Kung University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: January 2013
• Completion date: August 2014