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

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

Phase: Phase 4

Status: 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

Overall contact:
Ting-Hsing Chao, MD, Phone: 886-6-2353535, Ext: 2382, Email: chaoth@mail.ncku.edu.tw

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 Details

Official title: Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells and Endothelial Function Mediated Through Modification of Vasculogenesis and Angiogenesis Factors in Patients With Stable Coronary Artery 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

Composite Major Adverse Cardiovascular Events (MACE)

composite major coronary events

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 4. assessment of long-term cardiovascular outcomes

Eligibility

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

Criteria:

Inclusion Criteria:

- stable CAD documented by stress test, computed tomography angiography or coronary

angiography or

- old myocardial infarction (>6 months)

- history and evidence of CAD

- history and evidence of cerebrovascular accident

- history and evidence of peripheral artery disease

- diabetes mellitus

- metabolic syndrome

- stage 3 to 5 chronic kidney disease

- at least 2 of the followings: male ≥45 years old or female ≥55 years old;

hypertension; current or past 3-year tobacco smoking; hyperlipidemia; family history of premature CAD (male <55 years old or female <65 years old) Exclusion Criteria:

- unstable CAD

- have plan to do percutaneous intervention or bypass surgery for CAD or peripheral

artery disease within recent 3 months

- 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

Ting-Hsing Chao, MD, Phone: 886-6-2353535, Ext: 2382, Email: chaoth@mail.ncku.edu.tw

National Cheng Kung University Hospital, Tainan 704, Taiwan; Recruiting
Ting-Hsing Chao, MD, Phone: 886-6-2353535, Ext: 2382, Email: chaoth@mail.ncku.edu.tw
Ting-Hsing Chao, MD, Principal Investigator
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: February 2014
Last updated: December 5, 2014

Page last updated: August 23, 2015

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