Effect of Cilostazol Endothelial Progenitor Cells and Collateral Formation in Peripheral Occlusive Artery Disease (PAOD)

• Status: Completed
• Trial end date: 2013-09-01
• 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 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.

• 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:

• 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