DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Summary

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

Eligibility

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

Criteria:

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

excluded)

- left ventricular ejection fraction <50% by echocardiography

- documented active malignancy

- chronic inflammatory disease

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

months

- 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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017