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

Information source: National Cheng-Kung University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Diseases

Intervention: Cilostazol (Drug); Dummy Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: National Cheng-Kung University Hospital

Official(s) and/or principal investigator(s):
Ting-Hsing Chao, MD, Principal Investigator, Affiliation: National Cheng-Kung University Hospital


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 Details

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

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

Primary outcome: Circulating EPCs Number

Secondary outcome: Viability (Proliferation) of EPCs

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


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: high-risk patients who have at least one of the following situations without pre-existing cardiovascular disease including peripheral artery disease or coronary artery disease:

- type 2 diabetes mellitus

- metabolic syndrome

- stage 3 (or more advanced) chronic kidney disease

- 2 or more coronary risk factors (male > 45 years or female > 55 years, hypertension,

tobacco smoking, hyperlipidemia, family history of cardiovascular disease) Exclusion Criteria:

- ankle-brachial index less than 0. 9 or more than 1. 3 in one or both legs

- significant stenosis (more than 50% as compared to reference vessel) in peripheral

artery on image study

- symptoms suggesting peripheral artery disease in at least one leg

- clinical or electrocardiographic evidence of coronary artery disease

- clinical evidence of cerebrovascular disease

- severe liver dysfunction (transaminases >10 times of upper normal limit, history of

liver cirrhosis, or hepatoma)

- left ventricular ejection fraction (<50% by echocardiography)

- documented active malignancy

- chronic inflammatory disease

- known drug allergy history for cilostazol

- current use of cilostazol or any other cAMP-elevator

- premenopausal women

Locations and Contacts

National Cheng Kung University Hospital, Tainan 704, Taiwan
Additional Information

Related publications:

Chao TH, Tseng SY, Li YH, Liu PY, Cho CL, Shi GY, Wu HL, Chen JH. A novel vasculo-angiogenic effect of cilostazol mediated by cross-talk between multiple signalling pathways including the ERK/p38 MAPK signalling transduction cascade. Clin Sci (Lond). 2012 Aug 1;123(3):147-59. doi: 10.1042/CS20110432.

Biscetti F, Pecorini G, Straface G, Arena V, Stigliano E, Rutella S, Locatelli F, Angelini F, Ghirlanda G, Flex A. Cilostazol promotes angiogenesis after peripheral ischemia through a VEGF-dependent mechanism. Int J Cardiol. 2013 Aug 10;167(3):910-6. doi: 10.1016/j.ijcard.2012.03.103. Epub 2012 Apr 2.

Chao TH, Tseng SY, Chen IC, Tsai YS, Huang YY, Liu PY, Ou HY, Li YH, Wu HL, Cho CL, Tsai LM, Chen JH. Cilostazol enhances mobilization and proliferation of endothelial progenitor cells and collateral formation by modifying vasculo-angiogenic biomarkers in peripheral arterial disease. Int J Cardiol. 2014 Mar 15;172(2):e371-4. doi: 10.1016/j.ijcard.2013.12.295. Epub 2014 Jan 11.

Starting date: January 2013
Last updated: July 16, 2014

Page last updated: August 23, 2015

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