Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in High Risk for Cardiovascular Disease

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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, 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 high risk for cardiovascular disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Collaborator: Department of Health, Executive Yuan, R.O.C. (Taiwan)
• Treatments: Cilostazol

Criteria

Inclusion Criteria: 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 Criteria:

• 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