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

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: Peripheral Arterial Diseases

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

Phase: Phase 4

Status: Completed

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 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.

Clinical Details

Official title: 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

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: Colony Formation by 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

- 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


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


Inclusion Criteria:

- ankle-brachial index (ABI) less than 0. 9 in one or both legs but no obvious symptoms

of intermittent claudication Exclusion Criteria:

- obvious symptoms of intermittent claudication

- severe PAD (Fontaine grading > 3) or critical limb ischemia in at least one leg

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

liver cirrhosis, or hepatoma)

- > stage 4 chronic kidney disease (end-stage renal disease with chronic dialysis not


- left ventricular ejection fraction <50% by echocardiography

- documented active malignancy

- chronic inflammatory disease

- planned coronary intervention or endovascular therapy or bypass surgery within 3


- 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.

Starting date: January 2012
Last updated: July 16, 2014

Page last updated: August 23, 2015

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