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
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