Effect of Cilostazol on Endothelial Progenitor Cells & Endothelial

Status Recruiting

Clinical Trial 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.

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

4. assessment of long-term cardiovascular outcomes ;

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

Clinical Trial Details

NCT number	NCT02174939
Study type	Interventional
Source	National Cheng-Kung University Hospital
Contact	Ting-Hsing Chao, MD
Phone	886-6-2353535
Email	chaoth@mail.ncku.edu.tw
Status	Recruiting
Phase	Phase 4
Start date	February 2014
Completion date	December 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms