Status:
COMPLETED
Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in High Risk for Cardiovascular Disease
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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, placeb...
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 dumm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02194686
Start Date
January 1 2013
End Date
August 1 2014
Last Update
October 14 2015
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, 704